HFNC vs. NIV in Acute COPD Exacerbations

NCT06495086 | Completed DMC FDA Device

• 1 other identifier: 137-2023
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbations; Acute Hypercapnic Respiratory Failure; Respiratory Failure

Keywords

High-flow nasal cannula; Noninvasive ventilation; COPD exacerbations; efficacy; safety

Outcome Measures

Primary Outcomes (4)

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

  The investigators assessed the changes in pH before treatments vs. 30, 60, and 120 minutes after treatments.

  at 30, 60, and 120 minutes relative to baseline

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

  The investigators assessed the changes in PaCO2 before treatments vs. 30, 60, and 120 minutes after treatments.

  at 30, 60, and 120 minutes relative to baseline

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

  The investigators assessed the changes in lactate before treatments vs. 30, 60, and 120 minutes after treatments.

  at 30, 60, and 120 minutes relative to baseline

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

  The investigators assessed the changes in bicarbonate before treatments vs. 30, 60, and 120 minutes after treatments.

  at 30, 60, and 120 minutes relative to baseline

Secondary Outcomes (1)

• Assessing the need for rescue treatment and treatment-related complications

  120 minutes after initial treatment

Study Arms (3)

NIV group

ACTIVE COMPARATOR

The NIV group received bilevel-positive airway pressure.

Device: NIV

HFNC-30 group

ACTIVE COMPARATOR

HFNC-30 group received HFNC therapy at flow rates of 30 L/min.

Device: HFNC-30

HFNC-50 group

ACTIVE COMPARATOR

HFNC-50 group received HFNC therapy at flow rates of 50 L/min.

Device: HFNC-50

Interventions

NIV DEVICE

The NIV group received bilevel-positive airway pressure. During NIV, the tidal volume was set to 6-8 mL/kg, positive expiratory end pressure (PEEP) to 3-5 cm H2O, and pressure support ventilation (PSV) to 8-12 cm H2O by a clinician with 8 years of experience. To reduce potential bias, the clinician was blinded to the null hypothesis.

NIV group

HFNC-30 DEVICE

The HFNC-30 group received HFNC therapy at flow rates of 30 L/min. During HFNC, the humidifier was set to an open position, the heated air temperature was maintained at 37°C, and the FiO2 was adjusted to maintain an oxygen saturation (SpO2) measured via pulse oximetry of at least 92%.

HFNC-30 group

HFNC-50 DEVICE

The HFNC-50 group received HFNC therapy at flow rates of 50 L/min. During HFNC, the humidifier was set to an open position, the heated air temperature was maintained at 37°C, and the FiO2 was adjusted to maintain an oxygen saturation (SpO2) measured via pulse oximetry of at least 92%.

HFNC-50 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (5)

• Rezaei A, Fakharian A, Ghorbani F, Idani E, Abedini A, Jamaati H. Comparison of high-flow oxygenation with noninvasive ventilation in COPD exacerbation: A crossover clinical trial. Clin Respir J. 2021 Apr;15(4):420-429. doi: 10.1111/crj.13315. Epub 2020 Dec 22.

  PMID: 33269553 RESULT

• Liu S, Walline JH, Zhu H, Li Y, Wang C, Liu J. High-flow nasal cannula therapy with sequential noninvasive ventilation versus noninvasive ventilation alone as the initial ventilatory strategy in acute COPD exacerbations: study protocol for a randomized controlled trial. Trials. 2022 Dec 29;23(1):1060. doi: 10.1186/s13063-022-06963-w.

  PMID: 36581995 RESULT

• Cortegiani A, Longhini F, Madotto F, Groff P, Scala R, Crimi C, Carlucci A, Bruni A, Garofalo E, Raineri SM, Tonelli R, Comellini V, Lupia E, Vetrugno L, Clini E, Giarratano A, Nava S, Navalesi P, Gregoretti C; H. F.-AECOPD study investigators. High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial. Crit Care. 2020 Dec 14;24(1):692. doi: 10.1186/s13054-020-03409-0.

  PMID: 33317579 RESULT

• Rittayamai N, Phuangchoei P, Tscheikuna J, Praphruetkit N, Brochard L. Effects of high-flow nasal cannula and non-invasive ventilation on inspiratory effort in hypercapnic patients with chronic obstructive pulmonary disease: a preliminary study. Ann Intensive Care. 2019 Oct 22;9(1):122. doi: 10.1186/s13613-019-0597-5.

  PMID: 31641959 RESULT

• Haciosman O, Ergenc H, Az A, Dogan Y, Sogut O. A high-flow nasal cannula versus noninvasive ventilation in acute exacerbations of chronic obstructive pulmonary disease. Am J Emerg Med. 2025 Jan;87:38-43. doi: 10.1016/j.ajem.2024.10.043. Epub 2024 Oct 28.

  PMID: 39481328 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Adem Az, M.D.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this single-blind study, we assigned the participants randomly to one of three treatment groups using a computer-generated randomization program (SAS Institute, 1990). Each participant was assigned an identification number indicating their treatment group. An experienced clinician, who was blinded to the null hypothesis and did not participate in the evaluation of results, administered the treatments and recorded patient data on a pre-prepared case data form.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)