NCT01680783

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

August 29, 2012

Results QC Date

October 27, 2016

Last Update Submit

July 1, 2020

Conditions

Acute Respiratory Distress SyndromeShockVentilatory FailureCardiogenic Pulmonary Edema

Keywords

noninvasive ventilationacute hypoxemic respiratory failureAcute respiratory distress syndromeshock

Outcome Measures

Primary Outcomes (1)

  • Need for Endotracheal Intubation

    Number of patients requiring endotracheal intubation after application of helmet device

    6 weeks

Secondary Outcomes (5)

  • Hospital Length of Stay

    Duration of hospital stay

  • Number of Participants Functional Status After Discharge

    Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)

  • Ventilator-free Days

    number of days in the hospital

  • Hospital Mortality

    90 days

  • Intensive Care Unit Length of Stay

    4 weeks

Other Outcomes (4)

  • ICU Complications

    6 weeks

  • Readmission to the Intensive Care Unit

    6 weeks

  • Discharge Location

    6 weeks

  • +1 more other outcomes

Study Arms (2)

Usual Care

OTHER

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

Other: Noninvasive ventilation via facemask

Non invasive ventilation via helmet

EXPERIMENTAL

Patients requiring more than 8 hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet instead of face mask for treatment of respiratory failure

Device: Non invasive ventilation using a helmet hyperbaric device

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.

Also known as: Sea-Long medical treatment hood
Non invasive ventilation via helmet
Noninvasive ventilation via facemaskOTHER

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

Also known as: mechanical ventilation
Usual Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥18 years of age who require noninvasive ventilation via facemask for \>8hours
  • Intact airway protective gag reflex
  • Able to follow instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. 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. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.

    PMID: 27179847DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeShockHypoventilationRespiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Results Point of Contact

Title
John P. Kress
Organization
University of Chicago
jkress@medicine.bsd.uchicago.edu
7737026790

Study Officials

  • John P Kress, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 14, 2020

Results First Posted

July 2, 2017

Record last verified: 2020-07

Locations

US(1)