Clinical trial NCT06495086: HFNC vs. NIV in Acute COPD Exacerbations
Official title: A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Single-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbations
Acute Hypercapnic Respiratory Failure
Respiratory Failure
Keywords: High-flow nasal cannula
Noninvasive ventilation
COPD exacerbations
efficacy
safety
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single center
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in pH in arterial blood gas before vs. after treatment
timeFrame: at 30, 60, and 120 minutes relative to baseline
measure: Changes in PaCO2 in arterial blood gas before vs. after treatment
timeFrame: at 30, 60, and 120 minutes relative to baseline
measure: Changes in lactate in arterial blood gas before vs. after treatment
timeFrame: at 30, 60, and 120 minutes relative to baseline
measure: Changes in bicarbonate in arterial blood gas before vs. after treatment
timeFrame: at 30, 60, and 120 minutes relative to baseline
Secondary outcomes:
measure: Assessing the need for rescue treatment and treatment-related complications
timeFrame: 120 minutes after initial treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
state: Fatih
Study officials:
affiliation: Haseki Training and Research Hospital
name: Adem Az, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.