Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904652
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-05-31
Brief Title:
High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
A Randomised Feasibility Trial of Simultaneous Application of Flow at Extubation SAFEx in Patients Requiring Intubation and Ventilation for the Management of Acute Respiratory Failure
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
Pre-SAFEx
Brief Summary:
The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties The main questions it aims to answer are
What is the recruitment rate to the study over 12 months
Is the study design acceptable and safe to participants
Participants will receive high flow nasal oxygen before their breathing tube is removed The investigators will compare this with standard practice of applying conventional low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion
The investigators hypothesise that they will recruit 30 participants to the study protocol 15 participants in each group over 12 months and that our study protocol will be tolerable and acceptable to participants
What is the recruitment rate to the study over 12 months
Is the study design acceptable and safe to participants
Participants will receive high flow nasal oxygen before their breathing tube is removed The investigators will compare this with standard practice of applying conventional low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion
The investigators hypothesise that they will recruit 30 participants to the study protocol 15 participants in each group over 12 months and that our study protocol will be tolerable and acceptable to participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None