HFNC vs. NIV in Acute COPD Exacerbations (HFNCstdy)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Acute Hypercapnic Respiratory Failure; COPD Exacerbations
• Intervention / Treatment: Device: NIV; Device: HFNC-30; Device: HFNC-50

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 Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34265
      • Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIV group; The NIV group received bilevel-positive airway pressure.	Device: NIV; 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.
Active Comparator: HFNC-30 group; HFNC-30 group received HFNC therapy at flow rates of 30 L/min.	Device: HFNC-30; 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%.
Active Comparator: HFNC-50 group; HFNC-50 group received HFNC therapy at flow rates of 50 L/min.	Device: HFNC-50; 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital
• Investigators: Principal Investigator: Adem Az, M.D., Haseki Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: safety; efficacy; COPD exacerbations; Noninvasive ventilation; High-flow nasal cannula
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: 137-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Stored in non-publicly available Available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes