COPD ExacerbationsHFNCstdyNCT06495086
HFNC vs. NIV in Acute COPD Exacerbations
A study testing NIV, HFNC-30 and HFNC-50 in people with COPD Exacerbations and Acute Hypercapnic Respiratory Failure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbations, Acute Hypercapnic Respiratory Failure, Respiratory Failure
- What is being tested?
- NIV, HFNC-30 and HFNC-50
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Fatih, 34265
About this study
Official title: 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.
Read the 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.
- Being tested
- NIV, HFNC-30, HFNC-50
- Keywords
- High-flow nasal cannula, Noninvasive ventilation, COPD exacerbations, efficacy, safety
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
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.
HFNC-30Device
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-50Device
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%.
| Study group | Role | What they receive |
|---|---|---|
| NIV group | Active comparator | The NIV group received bilevel-positive airway pressure. Receives: Device: NIV |
| HFNC-30 group | Active comparator | HFNC-30 group received HFNC therapy at flow rates of 30 L/min. Receives: Device: HFNC-30 |
| HFNC-50 group | Active comparator | HFNC-50 group received HFNC therapy at flow rates of 50 L/min. Receives: Device: HFNC-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 30, 60, and 120 minutes relative to baseline
Secondary outcomes (1)
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.
Measured: 120 minutes after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Az, Haseki Training and Research Hospital
- Investigators
- Adem Az, M.D., Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495086
- Sponsor's protocol ID
- 137-2023
- Acronym
- HFNCstdy
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Stored in non-publicly available Available on request
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.
PubMed 33269553Liu 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.
PubMed 36581995Cortegiani 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.
PubMed 33317579Rittayamai 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.
PubMed 31641959Haciosman 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.
PubMed 39481328
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Single-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06495086
- Acronym / sponsor ID
- HFNCstdy / 137-2023
- Keywords
- High-flow nasal cannula, Noninvasive ventilation, COPD exacerbations, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single center
| Arm | Type | Receives |
|---|---|---|
| NIV group | Active comparator | Device: NIVThe NIV group received bilevel-positive airway pressure. |
| HFNC-30 group | Active comparator | Device: HFNC-30HFNC-30 group received HFNC therapy at flow rates of 30 L/min. |
| HFNC-50 group | Active comparator | Device: HFNC-50HFNC-50 group received HFNC therapy at flow rates of 50 L/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIVThe 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. | Device | NIV group |
| HFNC-30The 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%. | Device | HFNC-30 group |
| HFNC-50The 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%. | Device | HFNC-50 group |
Primary outcome
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 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.
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 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.
1 secondary outcome
Assessing the need for rescue treatment and treatment-related complications
Time frame: 120 minutes after initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Results publication: PubMed 33269553Rezaei 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.
- Results publication: PubMed 36581995Liu 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.
- Results publication: PubMed 33317579Cortegiani 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.
- Results publication: PubMed 31641959Rittayamai 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.
- Derived from this study: PubMed 39481328Haciosman 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.
- Individual participant dataSharing planned: No. Stored in non-publicly available Available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adem Az, M.D. principal investigator
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV, HFNC-30 and HFNC-50 in people with COPD Exacerbations and Acute Hypercapnic Respiratory Failure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pH in arterial blood gas before vs. after treatment (time frame: at 30, 60, and 120 minutes relative to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495086, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.