Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Corona Virus Disease; Noninvasive Ventilation; Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Treatments: Device: Non invasive ventilation via helmet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04507802

MRC-01-20-616

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Non invasive ventilation via helmet

Experimental group

Description:

Patients who require noninvasive ventilation via Face mask for more than 8 hours will continue using noninvasive ventilation via facemask.

Treatment:

Device: Non invasive ventilation via helmet

Non invasive ventilation via facemask

No Intervention group

Description:

Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask