CompletedNot Applicable

HFNC vs. NIV in Acute COPD Exacerbations

Turkey (Türkiye)137 participantsStarted 2023-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at 30, 60, and 120 minutes relative to baseline

Changes in PaCO2 in arterial blood gas before vs. after treatment

Timeframe: at 30, 60, and 120 minutes relative to baseline

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

Timeframe: at 30, 60, and 120 minutes relative to baseline

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

Timeframe: at 30, 60, and 120 minutes relative to baseline

Trial details

NCT IDNCT06495086

SponsorHaseki Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More COPD Exacerbations trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: at 30, 60, and 120 minutes relative to baseline

Changes in PaCO2 in arterial blood gas before vs. after treatment

Timeframe: at 30, 60, and 120 minutes relative to baseline

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

Timeframe: at 30, 60, and 120 minutes relative to baseline

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

Timeframe: at 30, 60, and 120 minutes relative to baseline