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

NCT01680783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2020-07-14

Study results available
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Summary

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

Conditions

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

Interventions

DEVICE

Non invasive ventilation using a helmet hyperbaric device

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.

OTHER

Noninvasive ventilation via facemask

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • John P Kress, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01680783 on ClinicalTrials.gov