Mechanical Ventilation Pressure HighNCT06168162
Effect of Individualized PEEP on Postoperative Pulmonary Complication in Bariatrics
A study testing titated PEEP to best static compliance in people with Mechanical Ventilation Pressure High and Bariatric Surgery Candidate, run by Ain Shams University at 1 site in Egypt.
Trial summary
Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Pressure High, Bariatric Surgery Candidate
- What is being tested?
- titated PEEP to best static compliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 May 2025
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients were eligible for participation if the met the following criteria
- Age between 18 and 60 years old.
- Body mass index > 40
- Laparoscopic bariatric elective surgery under general anesthesia.
- ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.
Who cannot join
- Previous lung surgery
- ASA status III or IV.
- Moderate to severe obstructive or restrictive lung disease .
- Persistant intraoperative hemodynamic instability .
- Need for postoperative mechanical ventilation
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
Ain shams university
Cairo, Cairo Governorate
FATHY tash, prof, REC-FMASU@med.asu.edu.eg
About this study
Official title: Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries
Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.
In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications
- Being tested
- titated PEEP to best static compliance
- Keywords
- ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titated PEEP to best static complianceOther
the Intraoperative PEEP will be titrated to best static compliance for each patient
| Study group | Role | What they receive |
|---|---|---|
| titrate PEEP | Experimental | individulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O Receives: Other: titated PEEP to best static compliance |
| standard | Active comparator | standard PEEP of 5 cmH2O Receives: Other: titated PEEP to best static compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complication
pneumonia-atelactasis-bronchospasm-respiratory failure
Measured: postoperative 10 days after surgery
Secondary outcomes (1)
Pulmonary functions test
This test includes these values :FVC (forced vital capacity ) FEV1( forced expiratory volume in one sec ) FEV1% and FVC%
Measured: postoperative 1st , 3rd and 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation Pressure HighStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168162
- Sponsor's protocol ID
- FMASU MD259/2023
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT06168162
- Acronym / sponsor ID
- FMASU MD259/2023
- Keywords
- ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Dec 2023 (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.
Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.
In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| titrate PEEP | Experimental | Other: titated PEEP to best static complianceindividulaized PEEP starting 7cmH2O titrated to best static compliance (Cstat) ranging from 50 -100 cmH2O |
| standard | Active comparator | Other: titated PEEP to best static compliancestandard PEEP of 5 cmH2O |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were eligible for participation if the met the following criteria
Key exclusion criteria (5 listed)
- Previous lung surgery
- ASA status III or IV.
- Moderate to severe obstructive or restrictive lung disease .
- Persistant intraoperative hemodynamic instability .
- Need for postoperative mechanical ventilation
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 |
|---|---|---|
| titated PEEP to best static compliancethe Intraoperative PEEP will be titrated to best static compliance for each patient | Other | standard, titrate PEEP |
Primary outcome
postoperative pulmonary complication
Time frame: postoperative 10 days after surgery
pneumonia-atelactasis-bronchospasm-respiratory failure
1 secondary outcome
Pulmonary functions test
Time frame: postoperative 1st , 3rd and 5th day
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 17 Feb 2025.
- Individual participant dataSharing planned: Undecided. the results
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titated PEEP to best static compliance in people with Mechanical Ventilation Pressure High 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 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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 wessam selima, MD (+201001958858, w.z.selima@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complication (time frame: postoperative 10 days after surgery). 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 17 Feb 2025.