N/A N=83 Randomized Treatment

Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure

Acute Respiratory Distress Syndrome · Shock · Ventilatory Failure · Cardiogenic Pulmonary Edema

Bottom Line

View on ClinicalTrials.gov: NCT01680783 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Need for Endotracheal Intubation — 24; 8 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Non invasive ventilation using a helmet hyperbaric device (Device); Noninvasive ventilation via facemask (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: May 2016

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	—

Summary

The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.

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

View full record on ClinicalTrials.gov →

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.