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

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

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; 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; Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask; Other Names: mechanical ventilation
Experimental: 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	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 Names: Sea-Long medical treatment hood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Endotracheal Intubation	Number of patients requiring endotracheal intubation after application of helmet device	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Days spent in hospital at time of enrollment	Duration of hospital stay
Number of Participants Functional Status After Discharge	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)	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	Duration of mechanical ventilation via endotracheal tube	number of days in the hospital
Hospital Mortality	Death from any cause during hospitalization at time of enrollment	90 days
Intensive Care Unit Length of Stay	Number of days admitted to a medical intensive care unit	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Complications	ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness	6 weeks
Readmission to the Intensive Care Unit	Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment	6 weeks
Discharge Location	Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to	6 weeks
Improvement of Oxygenation	Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100	2 weeks

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: noninvasive ventilation; Acute respiratory distress syndrome; shock; acute hypoxemic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Edema; Hypoventilation
• Other Study ID Numbers: 12-1391