Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379607
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-10
Brief Title:
High Flow Nasal Cannula Rates in Pediatric Asthma
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a randomized open-label 3-armed feasibility trial will examine conventional oxygen therapy COT vs high flow nasal cannula at 4Lmin flow vs HFNC at 2Lkgmin flow max 60Lmin in moderate to severe pediatric asthma exacerbations
Detailed Description:
The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations Eligible patients will be admitted to the Pediatric Intensive Care Unit PICU after initial presentation to the emergency department ED or as a transfer from an outside hospital ED Patients will be admitted to the PICU on standard asthma therapy continuous albuterol and systemic corticosteroids based on the discretion of the treating ED physician Upon PICU admission eligible patients will be consented enrolled and randomized into the study All patients will be continued on standard asthma therapy of continuous albuterol at 20mghr and systemic intravenous corticosteroids Patient will be randomized into one of three groups 1 conventional oxygen therapy at 2Lmin via standard facemark control group 2 high flow nasal cannula at 4Lmin and 3 high flow nasal cannula at 2Lkgmin max 60Lmin Pediatric Respiratory Assessment Measure PRAM scores and vital signs will be taken at baseline and hourly for two hours After the two-hour long study is completed patients will be placed on a respiratory support modality as per the treating physicians discretion Patients will be followed longitudinally after study completion
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?:
None
Is an FDA AA801 Violation?:
None