Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome : A Randomized Clinical Trial
IMPORTANCE: Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients.
OBJECTIVE: To determine whether NIV delivered by helmet improves intubation rate among patients with ARDS.
DESIGN, SETTING, AND PARTICIPANTS: Single-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015.
INTERVENTIONS: Patients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group.
MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator-free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality.
RESULTS: Eighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, -43.3%; 95% CI, -62.4% to -24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, -22.3%; 95% CI, -43.3 to -1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers).
CONCLUSIONS AND RELEVANCE: Among patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01680783.
| Errataetall: |
CommentIn: JAMA. 2016 Jun 14;315(22):2401-3. - PMID 27179463 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:315 |
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| Enthalten in: |
JAMA - 315(2016), 22 vom: 14. Juni, Seite 2435-41 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Patel, Bhakti K [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 22.06.2016 Date Revised 26.09.2023 published: Print ClinicalTrials.gov: NCT01680783 CommentIn: JAMA. 2016 Jun 14;315(22):2401-3. - PMID 27179463 Citation Status MEDLINE |
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| doi: |
10.1001/jama.2016.6338 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM260353167 |
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| 100 | 1 | |a Patel, Bhakti K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome |b A Randomized Clinical Trial |
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| 500 | |a Date Revised 26.09.2023 | ||
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| 500 | |a ClinicalTrials.gov: NCT01680783 | ||
| 500 | |a CommentIn: JAMA. 2016 Jun 14;315(22):2401-3. - PMID 27179463 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a IMPORTANCE: Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients | ||
| 520 | |a OBJECTIVE: To determine whether NIV delivered by helmet improves intubation rate among patients with ARDS | ||
| 520 | |a DESIGN, SETTING, AND PARTICIPANTS: Single-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015 | ||
| 520 | |a INTERVENTIONS: Patients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group | ||
| 520 | |a MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator-free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality | ||
| 520 | |a RESULTS: Eighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, -43.3%; 95% CI, -62.4% to -24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, -22.3%; 95% CI, -43.3 to -1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers) | ||
| 520 | |a CONCLUSIONS AND RELEVANCE: Among patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings | ||
| 520 | |a TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01680783 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Wolfe, Krysta S |e verfasserin |4 aut | |
| 700 | 1 | |a Pohlman, Anne S |e verfasserin |4 aut | |
| 700 | 1 | |a Hall, Jesse B |e verfasserin |4 aut | |
| 700 | 1 | |a Kress, John P |e verfasserin |4 aut | |
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