N/A
Completed N=83
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
Source: ClinicalTrials.gov NCT01680783 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Need for Endotracheal Intubation — 24; 8 Participants
Summary
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Endotracheal Intubation |
24; 8 | — |
| SECONDARY Hospital Length of Stay |
15.2; 10.1 | — |
| SECONDARY Number of Participants Functional Status After Discharge |
6; 22 | — |
| SECONDARY Ventilator-free Days |
12.5; 28 | — |
| SECONDARY Hospital Mortality |
19; 12 | — |
| SECONDARY Intensive Care Unit Length of Stay |
7.8; 4.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥18 years of age who require noninvasive ventilation via facemask for >8hours
- Intact airway protective gag reflex
- Able to follow instructions
Exclusion Criteria
- Cardiopulmonary arrest
- Glasgow coma scale <8
- Absence of airway protective gag reflex
- Elevated intracranial pressure
- Tracheostomy
- Upper airway obstruction
- Pregnancy.
- Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Data sourced from ClinicalTrials.gov (NCT01680783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.