Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)

Official Title
-----------------
Comparison of The Clinical Outcomes of Non-Invasive Ventilation by Helmet vs Facemask in Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Noninvasive Ventilation, Corona Virus Disease

Intervention / Treatment
-----------------
* Device: Non invasive ventilation via helmet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition Age: 18 and more Exclusion Criteria: Patients with altered sensorium [Glasgow Coma Scale (GCS) less than 13] Pregnancy Hemodynamic instability Morbidly obese Patients with tracheostomy Severe acidosis [PH less than 7.15] Patients with glaucoma Patients with history of vertigo

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Experimental: Non invasive ventilation via helmet<br>Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask. | Device: Non invasive ventilation via helmet<br>* Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet<br>|
| No Intervention: Non invasive ventilation via facemask<br>Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask | |

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 |
| --- | --- | --- |
| Improvement in Oxygen Saturation | Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100 | 2 weeks | 
| Ventilator-free Days | Duration of mechanical ventilation via endotracheal tube | 28 days | 
| Intensive Care Unit Length of Stay | Number of days admitted to intensive care unit | 4 weeks | 
| Overall Mortality | Death from any cause during hospitalization at time of enrollment | 90 days | 
| Need for Proning | Need for proning during the hospital stay | up to 24 weeks | 
| Intensive Care Unit Mortality | Death from any cause during ICU hospitalization at time of enrollment | 28 days | 
| Patient Tolerability | the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance | 28 days from randomization |