Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495086
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
HFNC vs NIV in Acute COPD Exacerbations
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease A Single-blind Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
HFNCstdy
Brief Summary:
The investigators investigated the efficacy and safety of High Flow Nasal Cannula HFNC at different flow rates compared to non-invasive ventilation NIV in patients presenting to the emergency department ED with acute exacerbations of Chronic obstructive pulmonary disease COPD who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure Specifically the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide PaCO2 levels and hospital stay duration and would be associated with greater patient comfort than NIV
Detailed Description:
The patients were divided randomly into one of three study groups NIV HFNC-30 and HFNC-50 The investigators collected patient data including demographic characteristics age and sex vital signs upon admission systolic blood pressure SBP respiratory rate RR and heart rate HR complaints and symptoms upon admission initial arterial blood gas parameters eg pH PaCO2 lactate and bicarbonate length of stay ED revisits patient satisfaction intubation status and clinical outcomes hospitalization admission to the intensive care unit ICU or 28-day mortality Changes in arterial blood gas parameters eg ΔpH ΔPaCO2 Δlactate and Δbicarbonate before treatment vs 30 60 and 120 minutes after treatment were recorded using a pre-prepared case data form
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None