Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 12:02 PM
Study NCT ID:
NCT04035460
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula
Sponsor:
Baystate Medical Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVA-pilot
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: