Type II Respiratory FailureNCT06918288
Post-Extubation High-Flow Nasal Cannula Versus Non-Invasive Ventilation in Type II Respiratory Failure
A study testing High-Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in people with Type II Respiratory Failure and Hypercapnic Respiratory Failure, run by Benha University at 1 site in Egypt.
Trial summary
Acute hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation… Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Type II Respiratory Failure, Hypercapnic Respiratory Failure
- What is being tested?
- High-Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 15 Nov 2025
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years.
- Type II respiratory failure.
- Receiving invasive mechanical ventilation.
- Difficult weaning from invasive mechanical ventilation, defined as failure to wean after 3-7 days of weaning attempts.
- Fulfillment of predefined clinical criteria for extubation.
- Written informed consent.
Who cannot join
- Refusal to participate or absence of informed consent.
- Contraindication to NIV, including hemodynamic instability, excessive respiratory secretions with poor expectoration ability, oral or facial trauma, or recent esophageal surgery.
- Poor short-term prognosis, including a very high risk of death within 7 days or receipt of palliative care.
- Severe failure of another organ system, including severe cardiac, neurological, renal, or hepatic failure.
- Existing tracheostomy.
- Loss to follow-up resulting in uncertain 28-day survival.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Extubation Support Using Nasal Humidified High-Flow Oxygen Versus Non-Invasive Positive Pressure Mechanical Ventilation in Preventing Reintubation Among Patients With Type II Respiratory Failure
Acute hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation respiratory failure and reintubation. This randomized clinical trial compared high-flow nasal cannula (HFNC) with non-invasive ventilation (NIV) as respiratory support immediately after extubation in patients aged over 50 years with type II respiratory failure and difficult weaning. The primary objective was to compare reintubation rates at 72 hours and 7 days after extubation.
- Being tested
- High-Flow Nasal Cannula (HFNC), Non-Invasive Ventilation (NIV)
- Keywords
- Type II respiratory failure, Hypercapnia, Difficult weaning, Post-extubation, Reintubation, Non-invasive ventilation, High-flow nasal cannula
- Medical subject headings
- Hypoventilation, Respiratory Insufficiency, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Cannula (HFNC)Device
Heated and humidified high-flow oxygen was delivered through a nasal cannula immediately after extubation. The device provided adjustable high-flow oxygen to achieve the predefined oxygenation and respiratory-rate targets.
Non-Invasive Ventilation (NIV)Device
Positive-pressure ventilatory support was delivered immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) ventilation, with pressure and inspired oxygen adjusted according to predefined respiratory and gas-exchange targets.
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Nasal Cannula (HFNC) Group | Experimental | Participants randomized to this group received high-flow nasal cannula immediately after extubation. The initial airflow was set at 50 L/min and subsequently adjusted according to patient tolerance. Absolute humidity was set at 44 mg H2O/L and temperature at 37°C. Therapy was adjusted to maintain SpO2 between 88% and 92% and respiratory rate below 30 breaths/min or at the pre-extubation baseline. Escalation to NIV or invasive mechanical ventilation because of respiratory failure was considered HFNC treatment failure. Receives: Device: High-Flow Nasal Cannula (HFNC) |
| Non-Invasive Ventilation (NIV) Group | Active comparator | Participants randomized to this group received non-invasive ventilation immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) mode. Expiratory positive airway pressure was initially set at 4 cmH2O and inspiratory pressure at 8 cmH2O, with subsequent adjustment according to patient tolerance and to achieve a tidal volume of 6-8 mL/kg. Pressure support and FiO2 were adjusted to maintain SpO2 between 88% and 92%, respiratory rate ≤30 breaths/min or at the pre-extubation baseline, and PaCO2 between 45 and 60 mmHg or at the most recent pre-extubation value. Requirement for invasive mechanical ventilation was considered NIV treatment failure. Receives: Device: Non-Invasive Ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation Rate
Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation.
Measured: At 72 hours and 7 days after extubation
Secondary outcomes (8)
Treatment Failure Rate
Treatment failure was defined as escalation from HFNC to NIV or invasive mechanical ventilation in the HFNC group and requirement for invasive mechanical ventilation in the NIV group.
Measured: Within 48 hours after extubation
Ventilator-Free Days at Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
Measured: During the first 28 days after extubation
Duration of Post-Extubation Respiratory Support
Duration of respiratory support with HFNC or NIV following extubation.
Measured: Through 72 hours after extubation
Arterial Blood pH
Arterial blood pH measured by arterial blood gas analysis after extubation.
Measured: At 1, 12, 24, and 48 hours after extubation
Arterial Partial Pressure of Carbon Dioxide (PaCO2)
PaCO2 measured by arterial blood gas analysis after extubation.
Measured: At 1, 12, 24, and 48 hours after extubation
Arterial Bicarbonate (HCO3)
Arterial bicarbonate concentration measured as part of arterial blood gas analysis after extubation.
Measured: At 1, 12, 24, and 48 hours after extubation
PaO2/FiO2 Ratio
Ratio of arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2), used to assess oxygenation after extubation.
Measured: At 1, 12, 24, and 48 hours after extubation
Post-Extubation Complications
Incidence of post-extubation complications were recorded during follow-up in the HFNC and NIV groups.
Measured: From extubation through 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type II Respiratory FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) immediately after extubation.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Tarek Atwa Heikal, Benha University
- Investigators
- Ahmed Mostafa Abdelhamid, Professor of Anesthesia, Study director, Benha UniversityFatma Ahmed Abdelfattah, MD Anesthesia and intensive ca, Principal investigator, Benha UniversityMohamed Shaker Sadek, MD chest diseases, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918288
- Sponsor's protocol ID
- MD4-2-2025
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
PubMed 21765357Comellini V, Pacilli AMG, Nava S. Benefits of non-invasive ventilation in acute hypercapnic respiratory failure. Respirology. 2019 Apr;24(4):308-317. doi: 10.1111/resp.13469. Epub 2019 Jan 12.
PubMed 30636373
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Extubation Support Using Nasal Humidified High-Flow Oxygen Versus Non-Invasive Positive Pressure Mechanical Ventilation in Preventing Reintubation Among Patients With Type II Respiratory Failure
- ClinicalTrials.gov ID
- NCT06918288
- Acronym / sponsor ID
- MD4-2-2025
- Keywords
- Type II respiratory failure, Hypercapnia, Difficult weaning, Post-extubation, Reintubation, Non-invasive ventilation, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 9 Apr 2025 (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 hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation respiratory failure and reintubation. This randomized clinical trial compared high-flow nasal cannula (HFNC) with non-invasive ventilation (NIV) as respiratory support immediately after extubation in patients aged over 50 years with type II respiratory failure and difficult weaning. The primary objective was to compare reintubation rates at 72 hours and 7 days after extubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) immediately after extubation.
| Arm | Type | Receives |
|---|---|---|
| High-Flow Nasal Cannula (HFNC) Group | Experimental | Device: High-Flow Nasal Cannula (HFNC)Participants randomized to this group received high-flow nasal cannula immediately after extubation. The initial airflow was set at 50 L/min and subsequently adjusted according to patient tolerance. Absolute humidity was set at 44 mg H2O/L and temperature at 37°C. Therapy was adjusted to maintain SpO2 between 88% and 92% and respiratory rate below 30 breaths/min or at the pre-extubation baseline. Escalation to NIV or invasive mechanical ventilation because of respiratory failure was considered HFNC treatment failure. |
| Non-Invasive Ventilation (NIV) Group | Active comparator | Device: Non-Invasive Ventilation (NIV)Participants randomized to this group received non-invasive ventilation immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) mode. Expiratory positive airway pressure was initially set at 4 cmH2O and inspiratory pressure at 8 cmH2O, with subsequent adjustment according to patient tolerance and to achieve a tidal volume of 6-8 mL/kg. Pressure support and FiO2 were adjusted to maintain SpO2 between 88% and 92%, respiratory rate ≤30 breaths/min or at the pre-extubation baseline, and PaCO2 between 45 and 60 mmHg or at the most recent pre-extubation value. Requirement for invasive mechanical ventilation was considered NIV treatment failure. |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >50 years.
- Type II respiratory failure.
- Receiving invasive mechanical ventilation.
- Difficult weaning from invasive mechanical ventilation, defined as failure to wean after 3-7 days of weaning attempts.
- Fulfillment of predefined clinical criteria for extubation.
Key exclusion criteria (6 listed)
- Refusal to participate or absence of informed consent.
- Contraindication to NIV, including hemodynamic instability, excessive respiratory secretions with poor expectoration ability, oral or facial trauma, or recent esophageal surgery.
- Poor short-term prognosis, including a very high risk of death within 7 days or receipt of palliative care.
- Severe failure of another organ system, including severe cardiac, neurological, renal, or hepatic failure.
- Existing tracheostomy.
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 |
|---|---|---|
| High-Flow Nasal Cannula (HFNC)Heated and humidified high-flow oxygen was delivered through a nasal cannula immediately after extubation. The device provided adjustable high-flow oxygen to achieve the predefined oxygenation and respiratory-rate targets. | Device | High-Flow Nasal Cannula (HFNC) Group |
| Non-Invasive Ventilation (NIV)Positive-pressure ventilatory support was delivered immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) ventilation, with pressure and inspired oxygen adjusted according to predefined respiratory and gas-exchange targets. | Device | Non-Invasive Ventilation (NIV) Group |
Primary outcome
Reintubation Rate
Time frame: At 72 hours and 7 days after extubation
Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation.
8 secondary outcomes
Treatment Failure Rate
Time frame: Within 48 hours after extubation
Ventilator-Free Days at Day 28
Time frame: During the first 28 days after extubation
Duration of Post-Extubation Respiratory Support
Time frame: Through 72 hours after extubation
Arterial Blood pH
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Bicarbonate (HCO3)
Time frame: At 1, 12, 24, and 48 hours after extubation
PaO2/FiO2 Ratio
Time frame: At 1, 12, 24, and 48 hours after extubation
Post-Extubation Complications
Time frame: From extubation through 28 days after randomization
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 25 Aug 2026.
- Background: PubMed 21765357Thille AW, Harrois A, Schortgen F, Brun-Buisson C, Brochard L. Outcomes of extubation failure in medical intensive care unit patients. Crit Care Med. 2011 Dec;39(12):2612-8. doi: 10.1097/CCM.0b013e3182282a5a.
- Background: PubMed 30636373Comellini V, Pacilli AMG, Nava S. Benefits of non-invasive ventilation in acute hypercapnic respiratory failure. Respirology. 2019 Apr;24(4):308-317. doi: 10.1111/resp.13469. Epub 2019 Jan 12.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Type II Respiratory Failure
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Ahmed Mostafa Abdelhamid, Professor of Anesthesia study director
Benha University
Fatma Ahmed Abdelfattah, MD Anesthesia and intensive ca principal investigator
Benha University
Mohamed Shaker Sadek, MD chest diseases study chair
Benha 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 High-Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in people with Type II Respiratory Failure and Hypercapnic Respiratory Failure, run by Benha 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 6 inclusion and 6 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 25 Aug 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?
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?
Reintubation Rate (time frame: At 72 hours and 7 days after extubation). 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 NCT06918288, which also lists 2 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 25 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.