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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Respiratory Distress Syndrome, Shock, Ventilatory Failure, Cardiogenic Pulmonary Edema

Intervention / Treatment
-----------------
* Device: Non invasive ventilation using a helmet hyperbaric device
* Other: Noninvasive ventilation via facemask


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br>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<br>* Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask<br>* Other names: mechanical ventilation;|
| Experimental: Non invasive ventilation via helmet<br>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<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive ventilation, acute hypoxemic respiratory failure, Acute respiratory distress syndrome, shock