RecruitmentNCT07525232
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
A study testing sustained inflation recruitement and Stepwise PEEP in people with Recruitment and Bariatric Surgery Candidate, run by Ain Shams University at 1 site in Egypt.
Trial summary
Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recruitment, Bariatric Surgery Candidate
- What is being tested?
- sustained inflation recruitement and Stepwise PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2026to 1 Dec 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
- Anesthesiologists (ASA) physical status II, of either sex Age ≥18 y.
- Undergoing laparoscopic bariatric surgeries; sleeve gastrectomy, mini gastric bypass
- BMI (35-60)
Who cannot join
- Pre-existing severe pulmonary disease
- Baseline hypoxemia SpO₂ <92% on room air
- History of barotrauma
- Previous pneumothorax
- Known pulmonary bullae or emphysematous blebs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Stepwise PEEP vs Sustained Inflation Recruitment Maneuvers on Postoperative Oxygenation and Atelectasis in Bariatric Surgery Patients
Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective
Read the detailed description
In the SI group:, the anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator will be switched to manual mode, and the airway pressure-limiting valve will be set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O was achieved. This pressure was maintained continuously for 30 seconds. Following the maneuver, mechanical ventilation was resumed with positive end-expiratory pressure (PEEP) back to 5 cmho In the IP group:, alveolar recruitment will be performed as follows: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O (so peep will reach 20), held for 30 s , then PEEP will be gradually reduced at intervals of 5 cmH2O down to 5 cmH2O, when initial volume control ventilation will be resumed. In the incremental PEEP group, PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O was achieved, after which mechanical ventilation was resumed with maintenance PEEP. The total duration of the recruitment maneuver was approximately 60-90 seconds.
- Conditions
- Recruitment, Bariatric Surgery Candidate
- Being tested
- sustained inflation recruitement, Stepwise PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sustained inflation recruitementProcedure or surgery
anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator was switched to manual mode, and the airway pressure-limiting valve was set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O
Stepwise PEEPProcedure or surgery
: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| group SI | Active comparator | receive 30 cmH₂O sustained inflation for 30seconds Receives: Procedure: sustained inflation recruitement |
| group IP | Active comparator | receive PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O Receives: Procedure: Stepwise PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative lung aeration
limited-zone lung ultrasound scoring system
Measured: in the post-anesthesia care unit 15 minutes after extubation
Secondary outcomes (2)
Postoperative oxygenation
SpO₂
Measured: in the post-anesthesia care unit 15 minutes after extubation
Oxygen requirement in PACU
to maintain SpO₂ ≥94%.
Measured: in the post-anesthesia care unit 15 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start19 Apr 2026
- Primary completion24 Oct 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fouad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525232
- Sponsor's protocol ID
- FMASU R58/2026
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stepwise PEEP vs Sustained Inflation Recruitment Maneuvers on Postoperative Oxygenation and Atelectasis in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT07525232
- Acronym / sponsor ID
- FMASU R58/2026
- Conditions
- Recruitment, Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Apr 2026 (actual)
- Primary completion
- 24 Oct 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Apr 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.
Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective
Detailed description
In the SI group:, the anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator will be switched to manual mode, and the airway pressure-limiting valve will be set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O was achieved. This pressure was maintained continuously for 30 seconds. Following the maneuver, mechanical ventilation was resumed with positive end-expiratory pressure (PEEP) back to 5 cmho In the IP group:, alveolar recruitment will be performed as follows: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O (so peep will reach 20), held for 30 s , then PEEP will be gradually reduced at intervals of 5 cmH2O down to 5 cmH2O, when initial volume control ventilation will be resumed. In the incremental PEEP group, PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O was achieved, after which mechanical ventilation was resumed with maintenance PEEP. The total duration of the recruitment maneuver was approximately 60-90 seconds.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group SI | Active comparator | Procedure: sustained inflation recruitementreceive 30 cmH₂O sustained inflation for 30seconds |
| group IP | Active comparator | Procedure: Stepwise PEEPreceive PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Anesthesiologists (ASA) physical status II, of either sex Age ≥18 y.
- Undergoing laparoscopic bariatric surgeries; sleeve gastrectomy, mini gastric bypass
- BMI (35-60)
Key exclusion criteria (5 listed)
- Pre-existing severe pulmonary disease
- Baseline hypoxemia SpO₂ <92% on room air
- History of barotrauma
- Previous pneumothorax
- Known pulmonary bullae or emphysematous blebs
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 |
|---|---|---|
| sustained inflation recruitementanesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator was switched to manual mode, and the airway pressure-limiting valve was set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O | Procedure or surgery | group SI |
| Stepwise PEEP: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O | Procedure or surgery | group IP |
Primary outcome
Postoperative lung aeration
Time frame: in the post-anesthesia care unit 15 minutes after extubation
limited-zone lung ultrasound scoring system
2 secondary outcomes
Postoperative oxygenation
Time frame: in the post-anesthesia care unit 15 minutes after extubation
Oxygen requirement in PACU
Time frame: in the post-anesthesia care unit 15 minutes after extubation
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sustained inflation recruitement and Stepwise PEEP in people with Recruitment and Bariatric Surgery Candidate, run by Ain Shams 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 3 inclusion and 5 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 27 Oct 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?
Postoperative lung aeration (time frame: in the post-anesthesia care unit 15 minutes after extubation). 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 27 Oct 2026.