NCT04035460

A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula

A Pilot Randomized Controlled Study of Non-invasive Oxygenation and Ventilation in Patients With Acute Hypoxemic Respiratory Failure (AHRF): A Comparison of Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula (HFNC)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Baystate Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our main objective is to collect feasibility data on helmet NIPPV and other clinical elements in to eventually prepare for a full scale randomized trial based on findings of this pilot study.

Detailed description

Patients with acute hypoxemia leading to respiratory failure are frequently supported by endotracheal intubation and mechanical ventilation. Unfortunately an invasive approach to support is associated with risks of lung injury, infection, need for heavy sedation, and increased mortality. Non-invasive oxygen delivery, by mask (BiPAP or CPAP), high flow nasal cannula or helmet interface, is better tolerated and reduces risks associated with invasive mechanical ventilation. A growing body of medical literature and clinical experience suggests that non-invasive oxygen delivery can prevent the need for endotracheal intubation in some patients. This proposal will compare two different modes of non-invasive oxygen delivery: helmet and high flow nasal cannula.

Conditions

• Hypoxemic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Helmet	The helmet encloses the head and neck of the patient, has a rigid ring and is secured by 2 armpit braces. A soft collar adheres to the neck and ensures a sealed connection once the helmet is inflated.
DEVICE	High Flow Nasal Oxygen	Large-bore nasal prongs through which oxygen is delivered at high flow rates

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2019-07-29
• Last updated: 2021-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study