Respiratory Failure Without HypercapniaNCT06988111
Management of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI)
A study testing BIPAP and Vapotherm in people with Respiratory Failure Without Hypercapnia and Respiratory Failure With Hypercapnia, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia, Postoperative Respiratory Complication
- What is being tested?
- BIPAP and Vapotherm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jan 2027
- 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
- Age above 18 years
- within 48 hours after major surgery
- PAO2/FIO2 less than 200
- Signs of respiratory distress and respiratory rate (RR) more than 25 cycles/minute
Who cannot join
- Age below 18 years
- Pregnant ladies
- Orofacial trauma or burns
- Active Gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assuit Univeristy
Asyut, Assuit, 71515
ahmed M. shaddad, MD, +201111171930, shaddad_ahmad@yahoo.com
shaddad_ahmad@yahoo.com
About this study
Official title: A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU) stays, and increased resource burden.
Read the detailed description
Noninvasive ventilation (NIV) and high-flow nasal cannula (HFNC) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. However, head-to-head data in patients with obstructive or restrictive pulmonary function (PORF) are scarce.
This protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. We hypothesize that NIV will reduce 72-hour reintubation rates compared to HFNC, translating into shorter ICU stays and lower costs.
Methodology \& Operational Workflow
- Screening \& Consent Identify eligible patients in the post-anesthesia care unit (PACU) or ICU. Obtain informed consent from the patient or legal surrogate.
- Baseline Assessment The baseline assessment includes demographics, comorbidities, and surgical data, as well as baseline arterial blood gases (ABG), vital signs, and comfort scores.
- Randomization \& Initiation Allocate via a secure web-based randomization module. Initiate assigned respiratory support within 30 minutes of notification.
- Monitoring \& Data Collection The patient is receiving continuous pulse oximetry and respiratory rate monitoring.
ABGs and fraction of inspired oxygen (FIO2) at 1 hour, 6 hours, and 24 hours. Comfort scores every six hours. Record interface-related adverse events.
- Escalation Criteria The patient exhibits persistent partial arterial oxygen pressure/fraction of inspired oxygen ratio (PaO2/FiO2) levels of less than 100, even at maximal settings.
Hemodynamic instability occurs due to the use of new-onset vasopressors. Deterioration leading to invasive ventilation → classified as "reintubation."
- Weaning Protocol. Transition to standard oxygen therapy when the flow or pressure is minimal.
- Follow-Up \& Discharge Track ICU length of stay (LOS), hospital LOS, and ventilation-free days (VFD). Keep a record of the 30-day survival rate and any readmissions.
- Statistical Analysis Plan Primary Endpoint: Compare reintubation rates using a χ² test; report the risk difference and 95% confidence interval.
- Missing Data: Multiple imputation for datasets with ≤ 5% missing data; sensitivity analysis for worst-case scenarios.
- Interim Analysis: After 50% enrollment, the Data Safety and Monitoring Board (DSMB) reviews efficacy and futility, using O'Brien-Fleming boundaries.
- Conditions
- Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia, Postoperative Respiratory Complication
- Being tested
- BIPAP, Vapotherm
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAPDevice
The second arm (NIV group) will be managed by BIPAP device for post-operative respiratory failure
VapothermDevice
Also called High-velocity nasal insufflation, High velocity nasal cannula
The first arm (HVNC group) will be managed by Vapotherm device for post-operative respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Ventilation group | Experimental | NIV Arm
* Device: Bi-level positive airway pressure (BiPAP) via oronasal mask.
* Initial settings: inspiratory positive airway pressure (IPAP) 10 cmH₂O, expiratory positive airway pressure (EPAP) 5 cmH₂O, and fraction of inspired oxygen (FiO₂) titrated to oxygen saturation (SpO₂) ≥ 92%.
* Weaning: Decrement IPAP/EPAP by 2 cmH₂O every four hours as tolerated. Receives: Device: BIPAP |
| High Velocity Nasal Cannula (HVNC) group | Experimental | HVNC Arm
* Device: Heated, humidified high-flow nasal cannula (HFNC) system.
* Initial flow: 50 L/min, fraction of inspired oxygen (FiO₂) titrated to SpO₂ ≥ 92%.
* Weaning: Reduce flow by 10 L/min every 4 h as tolerated. Receives: Device: Vapotherm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning success
The primary outcome will be comparing the weaning success (in days) for both arms of the study group. This will be accessed after 48 hours and on a daily basis until the weaning criteria are met or for 28 days.
Measured: At 48 hours and then daily for 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Dec 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure Without HypercapniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient with operative respiratory failure will be compared using NIV and High velocity nasal cannula devices
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. Shaddad, MD, Principal investigator, Assuit UniveristyAliae A. Hussien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988111
- Sponsor's protocol ID
- 375690
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available by Assiut University's institutional data-sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
- ClinicalTrials.gov ID
- NCT06988111
- Acronym / sponsor ID
- 375690
- Conditions
- Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia, Postoperative Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 May 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.
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU) stays, and increased resource burden.
Detailed description
Noninvasive ventilation (NIV) and high-flow nasal cannula (HFNC) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. However, head-to-head data in patients with obstructive or restrictive pulmonary function (PORF) are scarce.
This protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. We hypothesize that NIV will reduce 72-hour reintubation rates compared to HFNC, translating into shorter ICU stays and lower costs.
Methodology \& Operational Workflow
- Screening \& Consent Identify eligible patients in the post-anesthesia care unit (PACU) or ICU. Obtain informed consent from the patient or legal surrogate.
- Baseline Assessment The baseline assessment includes demographics, comorbidities, and surgical data, as well as baseline arterial blood gases (ABG), vital signs, and comfort scores.
- Randomization \& Initiation Allocate via a secure web-based randomization module. Initiate assigned respiratory support within 30 minutes of notification.
- Monitoring \& Data Collection The patient is receiving continuous pulse oximetry and respiratory rate monitoring.
ABGs and fraction of inspired oxygen (FIO2) at 1 hour, 6 hours, and 24 hours. Comfort scores every six hours. Record interface-related adverse events.
- Escalation Criteria The patient exhibits persistent partial arterial oxygen pressure/fraction of inspired oxygen ratio (PaO2/FiO2) levels of less than 100, even at maximal settings.
Hemodynamic instability occurs due to the use of new-onset vasopressors. Deterioration leading to invasive ventilation → classified as "reintubation."
- Weaning Protocol. Transition to standard oxygen therapy when the flow or pressure is minimal.
- Follow-Up \& Discharge Track ICU length of stay (LOS), hospital LOS, and ventilation-free days (VFD). Keep a record of the 30-day survival rate and any readmissions.
- Statistical Analysis Plan Primary Endpoint: Compare reintubation rates using a χ² test; report the risk difference and 95% confidence interval.
- Missing Data: Multiple imputation for datasets with ≤ 5% missing data; sensitivity analysis for worst-case scenarios.
- Interim Analysis: After 50% enrollment, the Data Safety and Monitoring Board (DSMB) reviews efficacy and futility, using O'Brien-Fleming boundaries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient with operative respiratory failure will be compared using NIV and High velocity nasal cannula devices
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Ventilation group | Experimental | Device: BIPAPNIV Arm * Device: Bi-level positive airway pressure (BiPAP) via oronasal mask. * Initial settings: inspiratory positive airway pressure (IPAP) 10 cmH₂O, expiratory positive airway pressure (EPAP) 5 cmH₂O, and fraction of inspired oxygen (FiO₂) titrated to oxygen saturation (SpO₂) ≥ 92%. * Weaning: Decrement IPAP/EPAP by 2 cmH₂O every four hours as tolerated. |
| High Velocity Nasal Cannula (HVNC) group | Experimental | Device: VapothermHVNC Arm * Device: Heated, humidified high-flow nasal cannula (HFNC) system. * Initial flow: 50 L/min, fraction of inspired oxygen (FiO₂) titrated to SpO₂ ≥ 92%. * Weaning: Reduce flow by 10 L/min every 4 h as tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years
- within 48 hours after major surgery
- PAO2/FIO2 less than 200
- Signs of respiratory distress and respiratory rate (RR) more than 25 cycles/minute
Key exclusion criteria (4 listed)
- Age below 18 years
- Pregnant ladies
- Orofacial trauma or burns
- Active Gastrointestinal bleeding
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 |
|---|---|---|
| BIPAPThe second arm (NIV group) will be managed by BIPAP device for post-operative respiratory failure | Device | Non-invasive Ventilation group |
| VapothermAlso: High-velocity nasal insufflation, High velocity nasal cannulaThe first arm (HVNC group) will be managed by Vapotherm device for post-operative respiratory failure | Device | High Velocity Nasal Cannula (HVNC) group |
Primary outcome
Weaning success
Time frame: At 48 hours and then daily for 28 days.
The primary outcome will be comparing the weaning success (in days) for both arms of the study group. This will be accessed after 48 hours and on a daily basis until the weaning criteria are met or for 28 days.
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available by Assiut University's institutional data-sharing policies.
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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.
Ahmad M. Shaddad, MD principal investigator
Assuit Univeristy
Aliae A. Hussien, MD 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 BIPAP and Vapotherm in people with Respiratory Failure Without Hypercapnia and Respiratory Failure With Hypercapnia, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Sep 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?
Contact Ahmad M. Shaddad, MD (+201111171930, shaddad_ahmad@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning success (time frame: At 48 hours and then daily for 28 days.). 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 22 Sep 2026.