COPDNCT07381686
High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure
A study testing Non-Invasive Ventilation (NIV) and High-Flow Nasal Cannula (HFNC) in people with COPD, run by Assiut University at 1 site in Egypt.
Trial summary
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Non-Invasive Ventilation (NIV) and High-Flow Nasal Cannula (HFNC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Severe acidosis or severe hypercapnia: pH < 7.30 or PaCO₂ > 60 mmHg requiring immediate escalation.
- Impending respiratory arrest or immediate need for re-intubation (severe hypoxemia, refractory distress, profound altered mental status).
- Severe hypoxemia not compatible with trial modalities (e.g., need for FiO₂ > 0.8 or PEEP > 10 cmH₂O to keep SpO₂ ≥ 88%).
- Hemodynamic instability: shock with rapidly escalating vasopressors, malignant arrhythmia, or active myocardial ischemia.
- Severe encephalopathy (GCS < 13) or inability to protect airway.
- Massive hemoptysis, active upper GIT bleeding, or untreated pneumothorax.
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- Post-extubation laryngeal edema/stridor requiring immediate re-intubation.
- Absolute/relative contraindications to NIV (mask-based): facial trauma/burns, recent facial/upper airway or gastric surgery, fixed upper airway obstruction, uncontrolled vomiting, severe agitation or mask intolerance.
- Contraindications to HFNC judged by the treating team (rare; e.g., complete nasal obstruction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure: A Prospective, Randomized Comparative Study
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group.
Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice.
High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).
Read the detailed description
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group.
Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice.
High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).
- Conditions
- COPD
- Being tested
- Non-Invasive Ventilation (NIV), High-Flow Nasal Cannula (HFNC)
- Keywords
- NIV,HFNC
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Ventilation (NIV)Device
In the NIV group, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results.
High-Flow Nasal Cannula (HFNC)Device
Patients assigned to the HFNC arm will receive oxygen through a high-flow nasal cannula connected to a heated humidifier, with flow rates titrated up to 60 L/min and FiO₂ adjusted to maintain target oxygen saturation (88-92%).
| Study group | Role | What they receive |
|---|---|---|
| NIV group | Experimental | using Non-Invasive Ventilation (NIV) as the intervention device, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results. Receives: Device: Non-Invasive Ventilation (NIV) |
| HFNC group | Experimental | using High-Flow Nasal Cannula (HFNC) as intervention device, Patients assigned to the HFNC arm will receive oxygen through a high-flow nasal cannula connected to a heated humidifier, with flow rates titrated up to 60 L/min and FiO₂ adjusted to maintain target oxygen saturation (88-92%). Receives: Device: High-Flow Nasal Cannula (HFNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure (need for reintubation within 72 hours).
Measured: within 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montaser Gamal Ahmed, Assiut University
- Investigators
- montaser gamal ahmed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381686
- Sponsor's protocol ID
- HFNC vs NIV in COPD weaning
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Nasal Cannula Versus Noninvasive Ventilation After Extubation in Patients With COPD and Mild Hypercapnic Respiratory Failure: A Prospective, Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07381686
- Acronym / sponsor ID
- HFNC vs NIV in COPD weaning
- Conditions
- COPD
- Keywords
- NIV,HFNC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group.
Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice.
High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).
Detailed description
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent a leading cause of hospital admissions and respiratory intensive care unit (RICU) stays worldwide. After invasive mechanical ventilation, many COPD patients experience difficulty in the weaning process, with a high hazard of extubation failure due to persistent hypercapnia and weakened respiratory muscle function (1). Extubation failure is allied with increased morbidity, prolonged ICU stay, and higher mortality (2). Thus, effective post-extubation respiratory support strategies are central for improving outcomes in this susceptible group.
Conventionally, noninvasive ventilation (NIV) has been the standard of care after extubation in COPD patients with mild to moderate hypercapnic respiratory failure, as it decreases work of breathing, improves gas exchange, and lowers reintubation rates (4). Though, NIV can be poorly tolerated due to mask-related discomfort, skin breakdown, claustrophobia, and patient-ventilator asynchrony (4).These limits often lead to suboptimal adherence and may compromise its efficacy in practice.
High-flow nasal cannula (HFNC) oxygen therapy has arisen as another, offering heated and humidified oxygen at high flows, which provides low-level positive airway pressure, washes out nasopharyngeal dead space, and improves patient comfort (5). Recent trials suggest that HFNC may be non-inferior to NIV in preventing post-extubation respiratory failure in high-risk populations (6). Yet, data specifically addressing COPD patients with mild hypercapnic respiratory failure remain inadequate, and no agreement exists regarding the optimal strategy in this subgroup. Thus, a direct comparative study between HFNC and NIV in this context is reasonable to guide clinical practice (7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV group | Experimental | Device: Non-Invasive Ventilation (NIV)using Non-Invasive Ventilation (NIV) as the intervention device, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results. |
| HFNC group | Experimental | Device: High-Flow Nasal Cannula (HFNC)using High-Flow Nasal Cannula (HFNC) as intervention device, Patients assigned to the HFNC arm will receive oxygen through a high-flow nasal cannula connected to a heated humidifier, with flow rates titrated up to 60 L/min and FiO₂ adjusted to maintain target oxygen saturation (88-92%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Severe acidosis or severe hypercapnia: pH < 7.30 or PaCO₂ > 60 mmHg requiring immediate escalation.
- Impending respiratory arrest or immediate need for re-intubation (severe hypoxemia, refractory distress, profound altered mental status).
- Severe hypoxemia not compatible with trial modalities (e.g., need for FiO₂ > 0.8 or PEEP > 10 cmH₂O to keep SpO₂ ≥ 88%).
- Hemodynamic instability: shock with rapidly escalating vasopressors, malignant arrhythmia, or active myocardial ischemia.
- Severe encephalopathy (GCS < 13) or inability to protect airway.
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 |
|---|---|---|
| Non-Invasive Ventilation (NIV)In the NIV group, a BiPAP machine will be used with an oronasal mask, adjusting inspiratory and expiratory pressures based on patient tolerance and ABG results. | Device | NIV group |
| High-Flow Nasal Cannula (HFNC)Patients assigned to the HFNC arm will receive oxygen through a high-flow nasal cannula connected to a heated humidifier, with flow rates titrated up to 60 L/min and FiO₂ adjusted to maintain target oxygen saturation (88-92%). | Device | HFNC group |
Primary outcome
Extubation failure (need for reintubation within 72 hours).
Time frame: within 72 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
montaser gamal ahmed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Ventilation (NIV) and High-Flow Nasal Cannula (HFNC) in people with COPD, run by Assiut University at 1 site in Egypt.
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 0 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Extubation failure (need for reintubation within 72 hours). (time frame: within 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.