Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Not Applicable

• Conditions: Acute Respiratory Distress Syndrome; Corona Virus Disease; Acute Respiratory Failure; Noninvasive Ventilation
• Interventions: Device: Non invasive ventilation via helmet

• Registration Number: NCT04507802
• Lead Sponsor: Hamad Medical Corporation

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-22
• Study Start: 2020-08
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-05
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Trial Locations

Locations (1)

Hazm Mebaireek General Hospital (HMGH); 🇶🇦 Doha, Qatar