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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Shock; Cardiogenic Pulmonary Edema; Ventilatory Failure
• Interventions: Device: Non invasive ventilation using a helmet hyperbaric device; Other: Noninvasive ventilation via facemask

• Registration Number: NCT01680783
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-29
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2016-10-27
• Results First Submitted QC: 2017-05-31
• Results First Posted: 2017-07-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non invasive ventilation via helmet	Non invasive ventilation using a helmet hyperbaric device	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
Usual Care	Noninvasive ventilation via facemask	Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

Primary Outcome Measures

Name	Time	Method
Need for Endotracheal Intubation	6 weeks	Number of patients requiring endotracheal intubation after application of helmet device

Secondary Outcome Measures

Name	Time	Method
Hospital Mortality	90 days	Death from any cause during hospitalization at time of enrollment
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)	Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
Hospital Length of Stay	Duration of hospital stay	Days spent in hospital at time of enrollment
Ventilator-free Days	number of days in the hospital	Duration of mechanical ventilation via endotracheal tube
Intensive Care Unit Length of Stay	4 weeks	Number of days admitted to a medical intensive care unit

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States