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

NCT ID: NCT01680783

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-05-31

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.

Detailed Description

Respiratory failure is often treated with endotracheal intubation and mechanical ventilation. Although, the institution of mechanical ventilation is considered life saving, the associated complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and neuromuscular weakness are not without considerable morbidity and mortality.

Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory failure in immunocompromised patients.

Despite the advantages of non-invasive ventilation via facemask, some patients fail because of mask intolerance and severity of disease. Further limitation to facemask non-invasive ventilation is that the seal integrity is lost when higher pressures are required. Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock may require such higher pressures.

In an attempt to improve patient tolerability and deliver higher pressures, a transparent helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the entire head and neck of the patient. The design of the helmet confers some important advantages: 1) the transparency allows the patient to interact with the environment; 2) the lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems of leaking with higher airway pressures that are seen with the face mask; 4) it can be applied to any patient regardless of facial contour.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: OTHER

Noninvasive ventilation via facemask

Intervention Type: OTHER

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

Non invasive ventilation via helmet

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

Group Type: EXPERIMENTAL

Non invasive ventilation using a helmet hyperbaric device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Noninvasive ventilation via facemask

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

Intervention Type: OTHER

Other Intervention Names

Sea-Long medical treatment hood; mechanical ventilation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Kress, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27179847 (View on PubMed)

Other Identifiers

12-1391

Identifier Type: -

Identifier Source: org_study_id