HFNC vs. NIV in Acute COPD Exacerbations

Not Applicable

Completed

• Conditions: Acute Hypercapnic Respiratory Failure; COPD Exacerbations; Respiratory Failure

• Registration Number: NCT06495086
• Lead Sponsor: Haseki Training and Research Hospital

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 (e.g., 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 (e.g., 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 Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy

Exclusion Criteria

• patients aged younger than 18 years
• patients had an arterial pH ≤ 7.25;
• patients were in cardiopulmonary arrest;
• patients had unstable cardiac arrhythmias or hemodynamic instability;
• patients showed persistent hypoxemia despite supplemental oxygen therapy;
• patients were unconscious or uncooperative;
• patients could not protect their airway or manage secretions;
• patients had cardiogenic pulmonary edema, active hemoptysis, pneumothorax, recent upper respiratory tract/esophagus surgery, significant airway obstruction (e.g., laryngeal mass or tracheal tumor), active upper gastrointestinal bleeding, or facial trauma or deformities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in pH in arterial blood gas before vs. after treatment	at 30, 60, and 120 minutes relative to baseline	The investigators assessed the changes in pH before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in bicarbonate in arterial blood gas before vs. after treatment	at 30, 60, and 120 minutes relative to baseline	The investigators assessed the changes in bicarbonate before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in lactate in arterial blood gas before vs. after treatment	at 30, 60, and 120 minutes relative to baseline	The investigators assessed the changes in lactate before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in PaCO2 in arterial blood gas before vs. after treatment	at 30, 60, and 120 minutes relative to baseline	The investigators assessed the changes in PaCO2 before treatments vs. 30, 60, and 120 minutes after treatments.

Secondary Outcome Measures

Name	Time	Method
Assessing the need for rescue treatment and treatment-related complications	120 minutes after initial treatment	The investigators assessed the need for invasive respiratory support and also evaluated treatment-related complications.

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Fatih, Turkey