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Clinical Trials/NCT06495086
NCT06495086
Completed
Not Applicable

A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Single-blind Randomized Trial

Haseki Training and Research Hospital1 site in 1 country137 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbations
Sponsor
Haseki Training and Research Hospital
Enrollment
137
Locations
1
Primary Endpoint
Changes in pH in arterial blood gas before vs. after treatment
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Haseki Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Adem Az

Principal Investigator

Haseki Training and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in pH in arterial blood gas before vs. after treatment

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Assessing the need for rescue treatment and treatment-related complications(120 minutes after initial treatment)

Study Sites (1)

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