Wir haben festgestellt, dass Sie unsere Website von Vereinigte Staaten aus besuchen.
Für Ihr Land (Vereinigte Staaten) gibt es eine eigene Version der Website.

Zu Vereinigte Staaten wechseln
HM_HF90 Hamilton Logo
 Experts on Air

Using HFOT guidelines. Right patient, right treatment, right time?

Webinar #1
1. Using the HFOT guidelines 2. Optimizing HFOT settings 3. Monitoring during HFOT 4. Intubation in hypoxemic respiratory failure 5. HFOT in hypercapnic respiratory failure 6. HFOT outside critical care
Experts-Air_HFNC_use-HFOT-guidelines_youtube
Video

1.  Using HFOT guidelines. Right patient, right treatment, right time? (Experts on Air)

Series 1, webinar 1: High flow oxygen therapy (HFOT)
Right patient, right treatment, right time? How to use HFOT guidelines
Speaker: Sharon Einav; Interviewer: Tommaso Mauri

Before initiating high flow oxygen therapy, we need to identify the patient’s criteria and adapt treatment based on clinical guidelines. This webinar looks at the different types of patients and how they can benefit from this therapy. Recorded on February 10, 2022; 15:00 (CET). (Subtitles automatically generated).
36 minutes
EN
Experts-Air_HFNC_Optimize-HFOT-settings_youtube
Video

2.  Optimizing HFOT settings

31 minutes
EN
Experts-Air_HFNC_Monitoring-during-nasal-HFOT_youtube
Video

3.  Monitoring during HFOT

37 minutes
EN
Experts-Air_HFNC_Intubation-hypoxemic-respiratory-failure_youtube
Video

4.  Intubation in hypoxemic respiratory failure

30 minutes
EN
Experts-Air_HFNC_Hypercapnic-respiratory-failure_youtube
Video

5.  HFOT in hypercapnic respiratory failure

31 minutes
EN
Experts-Air_HFNC_Outside-critical-care_youtube
Video

6.  HFOT outside critical care

35 minutes
EN

Q&A Webinar #1.

There is currently no known protocol for congenital heart surgery.

There is no formal protocol for weaning. (See the next webinar on February 24 about optimizing HFOT settings).

Data is clear on the benefit of CPAP, there is not enough literature on HFNO.

(a) In high risk/obese patients particularly after chest surgery and abdominal surgery. Also consider ENT if there are secretions. (b) There could be a possible issue with pressure on surgical sutures with NIV if it was gastric surgery. (c)  In failed HFNO, heart failure patients. You could also alternate HFNO with NIV. 

Prevention : HFNC is good for comfort and maybe shortened stays. Treatment:  This is unclear (not enough patients). NIV shows benefit but there is not enough head-to-head data.

There are three papers showing the cost-effectiveness of HFNC. It is obviously not for indiscriminate use.  For pediatrics, there is also literature justifying the use of HFNO for bronchiolitis: Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-71​, Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.19433422​, Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.234673​

There is also some cost-utility work on HFNO for COPD use at home which appears quite convincing: Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S3125234​.

Contraindications: Patient not awake / nobody to see/montior the patient (no alarms).

Mainly delayed intubation; possible P-SILI as well.

Not at all. The advantage of HFO is in the high flows. Hence, if there is no respiratory distress (i.e., low flows) and supplementation up to an FiO2 of 0.5-0.6 suffices, there is no need.

There are no RCTs but there are several interesting studies thus far:

COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-25​: “In patients with COVID-19, HFNC was associated with a reduction in oxygenation failure without improvement in 90-day mortality, whereas NIV was associated with a higher mortality in these patients. “

Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC6​: “We analyzed 184 and 131 patients receiving HFNO or NIV, respectively. 112 HFNO, and 69 NIV patients transitioned to IMV. 104 (92.9%) HFNO patients and 66 (95.7%) NIV patients continued to have PaO2/FiO2 ≤300 under IMV…. Overall mortality was 19.0% (35/184) and 24.4% (32/131) for HFNO and NIV, respectively (p=0.2479).”

Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.00287​: “Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy.”
This may be better than immediately intubating these patients…

Definitely yes, although the literature is still not sufficiently strong. There are no RCTs but there are several interesting studies thus far (see answer to previous question).

Yes, we use a specific connector for tracheostomy. Only in monitored areas. Not for patients who need suction more than 2 or more times each nursing shift (>twice in 8 hours).

Over COT and before NIV for all patients except heart failure.

Possibly looking forward there may be ways to identify these patients based on their aeration distributions (CT) and WOB (EiT). We are not there yet.

Helmet is the interface, not the mode of ventilation. Use of a helmet interface requires experience. We use it for patients who are cooperative and alternate it with HFNO since it limits communication and feeding.  

In terms of mode, BiPAP definitely first line only for pulmonary edema (heart failure). An interesting paper on helmet vs. HFNO for heart failure  (single center about 200 patients): Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab0788​

For COVID: 110 patients: Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.46829​

Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days.

We alternate based on the patients tolerance and response.

BiPAP definitely.

The problem is that mean apnea times in the studies for the metaanalysis were <2 minutes and even <1 in critical care patients. Also, most patients included in these studies were not with severe hypoxia, no data on difficult intubations, not enough on obesity (one study) and not on preganacy. So overall I agree with your clinical impression and we use it during intubations of patients with hypoxemia in our ICU.

There may be P-SILI with HFNO as well but this is vey diffucult to measure clinically. There is direct evidence of this in only neonatal cases with baro/volutrauma but we must assume the possibility exists in adults too.

At least 30 liters per minute. (See the upcoming webinar on optimizing HFOT settings on February 24.)

Disclaimer

The contents of this page are for informational purposes only and are not intended to be a substitute for professional training or for standard treatment guidelines in your facility. The responses to the questions on this page were prepared by the respective webinar's speaker;  any recommendations made here with respect to clinical practice or the use of specific products, technology, or therapies represent the personal opinion of the speaker only, and may not be considered as official recommendations made by Hamilton Medical AG. Hamilton Medical AG provides no warranty with respect to the information contained ion this page and reliance on any part of this information is solely at your own risk.

Referenzen

  1. 1. Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-7
  2. 2. Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.1943342
  3. 3. Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.23467
  4. 4. Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S312523
  5. 5. COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-2

 

  1. 6. Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC
  2. 7. Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.0028
  3. 8. Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab078
  4. 9. Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.4682

Fußnoten

 

The cost-utility of early use of high-flow nasal cannula in bronchiolitis.

Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-7



BACKGROUND

High-flow nasal cannula (HFNC) oxygen is a non-invasive ventilation system that was introduced as an alternative to CPAP (continuous positive airway pressure), with a marked increase in its use in pediatric care settings. This study aimed to evaluate the cost-effectiveness of early use of HFNC compared to oxygen by nasal cannula in an infant with bronchiolitis in the emergency setting.

METHODS

A decision tree model was used to estimate the cost-effectiveness of HFNC compared with oxygen by nasal cannula (control strategy) in an infant with bronchiolitis in the emergency setting. Cost data were obtained from a retrospective study on bronchiolitis from tertiary centers in Rionegro, Colombia, while utilities were collected from the literature.

RESULTS

The QALYs per patient calculated in the base-case model were 0.9141 (95% CI 0.913-0.915) in the HFNC and 0.9105 (95% CI 0.910-0.911) in control group. The cost per patient was US$368 (95% CI US$ 323-411) in HFNC and US$441 (95% CI US$ 384-498) per patient in the control group.

CONCLUSIONS

HFNC was cost-effective HFNC compared to oxygen by nasal cannula in an infant with bronchiolitis in the emergency setting. The use of this technology in emergency settings will allow a more efficient use of resources, especially in low-resource countries with high prevalence of bronchiolitis .

Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective.

Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.1943342



BACKGROUND

High-flow nasal cannula is a non-invasive ventilation system that was introduced as an alternative to continuous positive airway pressure), with a marked increase in its use in pediatric care settings. However, the expected budget impact of this intervention has not been explicitly estimated. This study aimed to evaluate the budget impact of the high-flow nasal cannula for acute bronchiolitis in Colombia.

METHODS

A budget impact analysis was performed to evaluate the potential financial impact deriving from high-flow nasal cannula during 2020. The analysis considered a 5-year time horizon and Colombian National Health System perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which a high-flow nasal cannula is reimbursed, from the cost of the conventional treatment without a high-flow nasal cannula (supplemental oxygen through a nasal cannula up to a maximum of 2 liters per minute). Univariate one-way sensitivity analyses were performed.

RESULTS

In the base-case analysis the 5-year costs associated with high-flow nasal cannula and no- high-flow nasal cannula were estimated to be US$159,585,618 and US$172,751,689 respectively, indicating savings for Colombian National Health equal to US$13,166,071 if the high-flow nasal cannula is adopted for the routine management of patients with acute bronchiolitis. This result was robust in univariate sensitivity one-way analysis.

CONCLUSION

High-flow nasal cannula was cost-saving in emergency settings for treating infants with acute bronchiolitis. This evidence can be used by decision-makers in our country to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis.

Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.23467

We evaluated the cost-effectiveness of high-flow nasal cannula (HFNC) to provide additional oxygen for infants with bronchiolitis, compared to standard low-flow therapy. The cost-effectiveness was evaluated by decision analyses, using decision tree modeling, and was based on real costs from our recently published retrospective case-control study. The data on the effectiveness of HFNC treatment were collected from earlier published retrospective studies, using admission rates to pediatric intensive care units (PICU). The analyses in the study showed that the expected treatment costs of each episode of infant bronchiolitis varied between €1,312-2,644 ($1,786-3,600) in the HFNC group and €1,598-3,764 ($2,175-5,125) in the standard treatment group. The PICU admission rates and consequential costs were lower for HFNC than for standard treatment. HFNC treatment proved more cost-effective than standard treatment in all the baseline analyses and was also more cost-effective in the sensitivity analyses, except for in the worst-case scenario analysis. In conclusion, our modeling demonstrated that HFNC was strongly cost-effective for infant bronchiolitis, compared to standard treatment because it was both more effective and less expensive. Thus, if children hospitalized for bronchiolitis need oxygen, it should be delivered as HFNC treatment. Pediatr Pulmonol. 2016;51:1393-1402. © 2016 Wiley Periodicals, Inc.

Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure.

Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S312523



PURPOSE

To evaluate the cost-effectiveness of long-term domiciliary high flow nasal cannula (HFNC) treatment in COPD patients with chronic respiratory failure.

PATIENTS AND METHODS

A cohort of 200 COPD patients were equally randomized into usual care ± HFNC and followed for 12 months. The outcome of the analysis was the incremental cost per quality-adjusted life-year (QALY) gained, and the analysis was conducted from a healthcare sector perspective. Data on the patients' health-related quality of life (HRQoL), gathered throughout the trial using the St. George's Respiratory Questionnaire (SGRQ), was converted into EQ-5D-3L health state utility values. Costs were estimated using Danish registers and valued in British pounds (£) at price level 2019. Scenario analyses and probabilistic sensitivity analyses were conducted to assess the uncertainty of the results.

RESULTS

The adjusted mean difference in QALYs between the HFNC group and the control group was 0.059 (95% CI: 0.017; 0.101), and the adjusted mean difference in total costs was £212 (95% CI: -1572; 1995). The analysis resulted in an incremental cost-effectiveness ratio (ICER) of £3605 per QALY gained. At threshold values of £20.000-30.000 per QALY gained, the intervention had an 83-92% probability of being cost-effective. The scenario analyses all revealed ICERs below the set threshold value and demonstrated the robustness of the main result.

CONCLUSION

This is the first cost-effectiveness study on domiciliary HFNC in Europe. The findings demonstrate that long-term domiciliary HFNC treatment is very likely to be a cost-effective addition to usual care for COPD patients with chronic respiratory failure. The results must be interpreted in light of the uncertainty associated with the indirect estimation of health state utilities.

Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals.

COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-2



RATIONAL

To evaluate the respective impact of standard oxygen, high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) on oxygenation failure rate and mortality in COVID-19 patients admitted to intensive care units (ICUs).

METHODS

Multicenter, prospective cohort study (COVID-ICU) in 137 hospitals in France, Belgium, and Switzerland. Demographic, clinical, respiratory support, oxygenation failure, and survival data were collected. Oxygenation failure was defined as either intubation or death in the ICU without intubation. Variables independently associated with oxygenation failure and Day-90 mortality were assessed using multivariate logistic regression.

RESULTS

From February 25 to May 4, 2020, 4754 patients were admitted in ICU. Of these, 1491 patients were not intubated on the day of ICU admission and received standard oxygen therapy (51%), HFNC (38%), or NIV (11%) (P < 0.001). Oxygenation failure occurred in 739 (50%) patients (678 intubation and 61 death). For standard oxygen, HFNC, and NIV, oxygenation failure rate was 49%, 48%, and 60% (P < 0.001). By multivariate analysis, HFNC (odds ratio [OR] 0.60, 95% confidence interval [CI] 0.36-0.99, P = 0.013) but not NIV (OR 1.57, 95% CI 0.78-3.21) was associated with a reduction in oxygenation failure). Overall 90-day mortality was 21%. By multivariable analysis, HFNC was not associated with a change in mortality (OR 0.90, 95% CI 0.61-1.33), while NIV was associated with increased mortality (OR 2.75, 95% CI 1.79-4.21, P < 0.001).

CONCLUSION

In patients with COVID-19, HFNC was associated with a reduction in oxygenation failure without improvement in 90-day mortality, whereas NIV was associated with a higher mortality in these patients. Randomized controlled trials are needed.

High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19.

Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC

Rationale: The "Berlin definition" of acute respiratory distress syndrome (ARDS) does not allow inclusion of patients receiving high-flow nasal oxygen (HFNO). However, several articles have proposed that criteria for defining ARDS should be broadened to allow inclusion of patients receiving HFNO. Objectives: To compare the proportion of patients fulfilling ARDS criteria during HFNO and soon after intubation, and 28-day mortality between patients treated exclusively with HFNO and patients transitioned from HFNO to invasive mechanical ventilation (IMV). Methods: From previously published studies, we analyzed patients with coronavirus disease (COVID-19) who had PaO2/FiO2 of ⩽300 while treated with ⩾40 L/min HFNO, or noninvasive ventilation (NIV) with positive end-expiratory pressure of ⩾5 cm H2O (comparator). In patients transitioned from HFNO/NIV to invasive mechanical ventilation (IMV), we compared ARDS severity during HFNO/NIV and soon after IMV. We compared 28-day mortality in patients treated exclusively with HFNO/NIV versus patients transitioned to IMV. Measurements and Main Results: We analyzed 184 and 131 patients receiving HFNO or NIV, respectively. A total of 112 HFNO and 69 NIV patients transitioned to IMV. Of those, 104 (92.9%) patients on HFNO and 66 (95.7%) on NIV continued to have PaO2/FiO2 ⩽300 under IMV. Twenty-eight-day mortality in patients who remained on HFNO was 4.2% (3/72), whereas in patients transitioned from HFNO to IMV, it was 28.6% (32/112) (P < 0.001). Twenty-eight-day mortality in patients who remained on NIV was 1.6% (1/62), whereas in patients who transitioned from NIV to IMV, it was 44.9% (31/69) (P < 0.001). Overall mortality was 19.0% (35/184) and 24.4% (32/131) for HFNO and NIV, respectively (P = 0.2479). Conclusions: Broadening the ARDS definition to include patients on HFNO with PaO2/FiO2 ⩽300 may identify patients at earlier stages of disease but with lower mortality.

Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial.

Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.0028



Importance

Continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) have been recommended for acute hypoxemic respiratory failure in patients with COVID-19. Uncertainty exists regarding the effectiveness and safety of these noninvasive respiratory strategies.

Objective

To determine whether either CPAP or HFNO, compared with conventional oxygen therapy, improves clinical outcomes in hospitalized patients with COVID-19-related acute hypoxemic respiratory failure.

Design, Setting, and Participants

A parallel group, adaptive, randomized clinical trial of 1273 hospitalized adults with COVID-19-related acute hypoxemic respiratory failure. The trial was conducted between April 6, 2020, and May 3, 2021, across 48 acute care hospitals in the UK and Jersey. Final follow-up occurred on June 20, 2021.

Interventions

Adult patients were randomized to receive CPAP (n = 380), HFNO (n = 418), or conventional oxygen therapy (n = 475).

Main Outcomes and Measures

The primary outcome was a composite of tracheal intubation or mortality within 30 days.

Results

The trial was stopped prematurely due to declining COVID-19 case numbers in the UK and the end of the funded recruitment period. Of the 1273 randomized patients (mean age, 57.4 [95% CI, 56.7 to 58.1] years; 66% male; 65% White race), primary outcome data were available for 1260. Crossover between interventions occurred in 17.1% of participants (15.3% in the CPAP group, 11.5% in the HFNO group, and 23.6% in the conventional oxygen therapy group). The requirement for tracheal intubation or mortality within 30 days was significantly lower with CPAP (36.3%; 137 of 377 participants) vs conventional oxygen therapy (44.4%; 158 of 356 participants) (absolute difference, -8% [95% CI, -15% to -1%], P = .03), but was not significantly different with HFNO (44.3%; 184 of 415 participants) vs conventional oxygen therapy (45.1%; 166 of 368 participants) (absolute difference, -1% [95% CI, -8% to 6%], P = .83). Adverse events occurred in 34.2% (130/380) of participants in the CPAP group, 20.6% (86/418) in the HFNO group, and 13.9% (66/475) in the conventional oxygen therapy group.

Conclusions and Relevance

Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy, and early study termination and crossover among the groups should be considered when interpreting the findings.

Trial Registration

isrctn.org Identifier: ISRCTN16912075.

Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial.

Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab078



AIMS

Non-invasive ventilation represents an established treatment for acute cardiogenic pulmonary oedema (ACPO) although no data regarding the best ventilatory strategy are available. We aimed to compare the effectiveness of helmet CPAP (hCPAP) and high flow nasal cannula (HFNC) in the early treatment of ACPO.

METHODS AND RESULTS

Single-centre randomized controlled trial of patients admitted to the emergency department due to ACPO with hypoxemia and dyspnoea on face mask oxygen therapy. Patients were randomly assigned with a 1:1 ratio to receive hCPAP or HFNC and FiO2 set to achieve an arterial oxygen saturation >94%. The primary outcome was a reduction in respiratory rate; secondary outcomes included changes in heart rate, PaO2/FiO2 ratio, Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score, Dyspnoea Scale, and intubation rate. Data were collected before hCPAP/HFNC placement and after 1 h of treatment. Amongst 188 patients randomized, hCPAP was more effective than HFNC in reducing respiratory rate [-12 (95% CI; 11-13) vs. -9 (95% CI; 8-10), P < 0.001] and was associated with greater heart rate reduction [-20 (95% CI; 17-23) vs. -15 (95% CI; 12-18), P = 0.042], P/F ratio improvement [+149 (95% CI; 135-163) vs. +120 (95% CI; 107-132), P = 0.003] as well as in HACOR scores [6 (0-12) vs. 4 (2-9), P < 0.001] and Dyspnoea Scale [4 (1-7) vs. 3.5 (1-6), P = 0.003]. No differences in intubation rate were noted (P = 0.321).

CONCLUSION

Amongst patients with ACPO, hCPAP resulted in a greater short-term improvement in respiratory and hemodynamic parameters as compared with HFNC.

TRIAL REGISTRATION

Clinical trial submission: NMRR-17-1839-36966 (IIR). Registry name: Medical Research and Ethics Committee of Malaysia Ministry of Health. Clinicaltrials.gov identifier: NCT04005092. URL registry: https://clinicaltrials.gov/ct2/show/NCT04005092.

Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial.

Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.4682



Importance

High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19.

Objective

To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone.

Design, Setting, and Participants

Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200).

Interventions

Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55).

Main Outcomes and Measures

The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay.

Results

Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99).

Conclusions and Relevance

Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation.

Trial Registration

ClinicalTrials.gov Identifier: NCT04502576.