CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
Non invasive ventilation using a helmet hyperbaric device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680783
NCT01680783N/ACompleted
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Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device

University of Chicago·interventional·Posted Sep 7, 2012·Updated Jul 14, 2020

In Brief

A clinical study evaluating Non invasive ventilation using a helmet hyperbaric device and Noninvasive ventilation via facemask for Acute Respiratory Distress Syndrome and 3 related conditions. Completed, enrolled 83 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome, Shock, Ventilatory Failure, Cardiogenic Pulmonary Edema
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.8 years ago

Interventions

Non invasive ventilation using a helmet hyperbaric devicedevice

Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.

Noninvasive ventilation via facemaskother

Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask