Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-04-14 @ 4:50 PM
Study NCT ID:
NCT02985918
Status:
TERMINATED
Last Update Posted:
2024-02-07
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Intensity vs Low-Intensity NPPV in Patients With an AECOPD: The HAPPEN Trial
Sponsor:
Beijing Chao Yang Hospital
Organization:
Study Overview
Official Title:
Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease The HAPPEN Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial has been terminated by the DSMB and the trial steering committee, based on the interim analysis results and the impracticality of continuing the trial in the context of the coronavirus disease 2019 (COVID-19) pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could reduce the need for endotracheal intubation during hospitalization in patients with an AECOPD and hypercapnia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: