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Directrices para la HFOT. ¿Cuál es el paciente, el tratamiento y el momento adecuados?

Seminario web 1

Preguntas y respuestas del seminario web 1

Actualmente no hay protocolos conocidos para este tipo de intervenciones.

No existen protocolos formales para la retirada. (No se pierda el seminario web del 24 de febrero sobre la optimización de los ajustes de la HFOT).

Los datos son claros en cuanto a los beneficios de la CPAP, pero no hay suficientes estudios sobre la HFNO.

(a) En pacientes obesos o de alto riesgo, especialmente después de una cirugía torácica y abdominal. También se puede valorar su uso para cirugías de ORL si hay secreciones. (b) La presión sobre las suturas quirúrgicas con la NIV podría suponer un problema en el caso de las cirugías gástricas. (c) En pacientes con insuficiencia cardíaca en los que ha fracasado la HFNO. También se podría alternar la HFNO con la NIV. 

Prevención: la HFNC es una buena opción en términos de comodidad del paciente y puede acortar la estancia hospitalaria. Tratamiento:  no existen datos claros (no hay pacientes suficientes). La NIV ha demostrado ofrecer beneficios, pero no contamos con suficientes datos comparativos.

Hay tres artículos en los que se explica la rentabilidad de la HFNC. Evidentemente, no se puede utilizar esta terapia indiscriminadamente.  En pediatría, también hay publicaciones que justifican el uso de la HFNO para el tratamiento de la bronquiolitis: 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

También existen algunos estudios acerca de la rentabilidad del uso de la HFNO para la EPOC en entornos de asistencia domiciliaria que parecen bastante convincentes: 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​.

Contraindicaciones: pacientes que no están despiertos o situaciones en que no hay nadie que pueda observar/monitorizar al paciente (sin alarmas).

Principalmente, el retraso de la intubación; también hay posibilidad de P‑SILI.

De ningún modo. La ventaja del HFO está en los elevados flujos que permite administrar. Por lo tanto, si no hay dificultad respiratoria (es decir, flujos bajos) y basta con administrar oxígeno suplementario hasta alcanzar una FiO2 del 0,5 al 0,6, no hay ninguna necesidad.

No se han realizado ensayos controlados aleatorizados, pero sí existen algunos estudios interesantes:

COVID‑ICU group, para la red REVA, 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.”
Podría ser mejor estrategia que intubar inmediatamente a esos pacientes…

Sin duda, aunque los estudios todavía no son lo bastante sólidos. No existen ensayos controlados aleatorizados, pero se han realizado algunos estudios interesantes (consulte la respuesta a la pregunta anterior):

Sí, utilizamos un conector específico para traqueotomía. Solo en áreas monitorizadas. No para pacientes que necesitan aspiración 2 veces o más en cada turno de enfermería (más de dos veces en 8 horas).

En lugar de la COT y antes que la NIV para todos los pacientes, excepto para aquellos con insuficiencia cardíaca.

Posiblemente en el futuro existan formas de identificar a estos pacientes basándose en la distribución de la oxigenación (TAC) y el esfuerzo respiratorio (TIE). Sin embargo, aún no ha llegado ese momento.

El casco es la interfaz, no el modo de ventilación. El uso de una interfaz tipo casco requiere experiencia. Lo utilizamos para pacientes que cooperan y lo alternamos con la HFNO, ya que limita la comunicación y la alimentación.  

En cuanto al modo, BiPAP es definitivamente el método de primera línea específico para casos de edema pulmonar (insuficiencia cardíaca). Un artículo interesante con una comparativa del uso de la interfaz tipo casco y la HFNO para la insuficiencia cardíaca (monocéntrico, con alrededor de 200 pacientes): 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

Para COVID: 110 pacientes: 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

Entre los pacientes con COVID‑19 e hipoxemia moderada a grave, el tratamiento con ventilación no invasiva con interfaz tipo casco, en comparación con la terapia con flujo alto nasal, no arrojó diferencias significativas en cuanto al número de días sin soporte respiratorio en un periodo de 28 días.

Alternamos en función de la tolerancia y la respuesta de los pacientes.

BiPAP, sin duda.

El problema reside en que los tiempos medios de apnea en los estudios de metaanálisis estuvieron por debajo de los 2 minutos, e incluso por debajo de 1 minuto, en pacientes de cuidados intensivos. Además, la mayoría de los pacientes incluidos en estos estudios no presentaba hipoxia grave, no había datos sobre intubaciones difíciles y no había datos suficientes sobre obesidad (un estudio) ni sobre embarazo. Por tanto, en general, estoy de acuerdo con su impresión clínica y lo usamos en las intubaciones de pacientes con hipoxemia en nuestra UCI.

También pueden producirse lesiones pulmonares autoinfligidas por el paciente (P‑SILI) con la HFNO, pero es muy difícil medir esto clínicamente. Solamente existen pruebas directas de ello en pacientes neonatos con barotrauma/volutrauma, pero debemos tener en cuenta que estas lesiones también se pueden dar en pacientes adultos.

Debe ser de al menos 30 litros por minuto. (No se pierda el próximo seminario web sobre la optimización de los ajustes de la HFOT, el 24 de febrero).

Exención de responsabilidad

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Referencias

  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

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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.