Obese Patients With Bariatric SurgeryNCT06950112
Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery
A study testing lung ultrasound in people with Obese Patients With Bariatric Surgery and Lung Ultrasound Score, run by Mahmoud Gamal Ahmed Arakeeb at 1 site in Egypt.
Trial summary
this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese Patients With Bariatric Surgery, Lung Ultrasound Score
- What is being tested?
- lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who have a BMI 30-40 kg/m2
- American Society of Anesthesiologists (ASA) physical status II or III
- patients aged between 18 and 60 years,
- patients scheduled to undergo laparoscopic bariatric surgeries.
Who cannot join
- patients' refusal to participate in the study,
- previous history of thoracic surgery,
- Patients with a history of chest disease (COPD, emphysema, or pneumothorax),
- Patients with abnormal pre-operative chest radiographs, such as pneumonia and pleural effusion,
- Patients with right-side heart failure or impending failure,
- Patients with known hypovolemia, and Patients with increased intracranial pressure.
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
Tanta university
Tanta, El Gharbia, 31527
Tanta University, +20403337544, dean@med.tanta.edu.eg
About this study
Official title: Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery: a Prospective Randomized Controlled Trial
this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score
- Being tested
- lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDevice
The lung ultrasound score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation). The aeration score will be built by the sum of the scores of the 12 segments, with a minimum of 0 and a maximum of 36 according to the aeration loss.
| Study group | Role | What they receive |
|---|---|---|
| Group D (Driving pressure) | Experimental | Patients will be ventilated with driving pressure-guided ventilation with VT 6-8 ml /kg of predicted body weight, and after recruitment, we will return to the baseline PEEP 5 cmH2O that will be increased by 2 cmH2O until reaching the lowest possible driving pressure for every patient. Each PEEP level will be maintained for ten respiratory cycles and DP will be calculated at the last cycle. Receives: Device: lung ultrasound |
| Group L (Lung protective strategy) | Experimental | Patients will be ventilated with protective lung strategy with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to PEEP of 8-10 cm H2O that will be maintained until the end of surgery. Receives: Device: lung ultrasound |
| Group P (Physiological PEEP) | Experimental | Patients will be ventilated with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to physiological PEEP of 5 cm H2O that will be maintained until the end of surgery. Receives: Device: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in lung ultrasound score
The primary outcome will be the change in Lung Ultra Sound Score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation) from the base line.
Measured: Periprocedural
Secondary outcomes (9)
Lung compliance
Lung compliance is a measure of the expansion of the lung.
Measured: Periprocedural
Hemodynamic parameter as oxygen saturation
Measured: Periprocedural
Hemodynamic parameter as Heart rate
Measured: Periprocedural
Hemodynamic parameter as Mean arterial blood pressure
Measured: Periprocedural
End-tidal carbon dioxide (ETCO2)
Measured: Periprocedural
Plateau Pressure (Pplat)
Measured: Periprocedural
Peak airway pressure (Ppeak)
Measured: Periprocedural
Incidence of early postoperative pulmonary complications
Measured: At the end of the surgery up to 24 hours after surgery
Length of post anesthesia care unit "PACU" stay.
Measured: At the end of the surgery up to 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Patients With Bariatric SurgeryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Gamal Ahmed Arakeeb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Gamal Ahmed Arakeeb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950112
- Sponsor's protocol ID
- 36265MD302/11/24
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Individualized PEEP Ventilation Guided by Driving Pressure and Conventional Lung Protective Strategy in Obese Patients Undergoing Laparoscopic Bariatric Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06950112
- Acronym / sponsor ID
- 36265MD302/11/24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahmoud Gamal Ahmed ArakeebUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 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.
this study to compare the ventilation in obese patients either using Driving pressure ventilation technique or conventional protective lung strategy all by using Lung ultrasound score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D (Driving pressure) | Experimental | Device: lung ultrasoundPatients will be ventilated with driving pressure-guided ventilation with VT 6-8 ml /kg of predicted body weight, and after recruitment, we will return to the baseline PEEP 5 cmH2O that will be increased by 2 cmH2O until reaching the lowest possible driving pressure for every patient. Each PEEP level will be maintained for ten respiratory cycles and DP will be calculated at the last cycle. |
| Group L (Lung protective strategy) | Experimental | Device: lung ultrasoundPatients will be ventilated with protective lung strategy with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to PEEP of 8-10 cm H2O that will be maintained until the end of surgery. |
| Group P (Physiological PEEP) | Experimental | Device: lung ultrasoundPatients will be ventilated with VT 6-8 ml /kg of predicted body weight, after recruitment we will return to physiological PEEP of 5 cm H2O that will be maintained until the end of surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who have a BMI 30-40 kg/m2
- American Society of Anesthesiologists (ASA) physical status II or III
- patients aged between 18 and 60 years,
- patients scheduled to undergo laparoscopic bariatric surgeries.
Key exclusion criteria (6 listed)
- patients' refusal to participate in the study,
- previous history of thoracic surgery,
- Patients with a history of chest disease (COPD, emphysema, or pneumothorax),
- Patients with abnormal pre-operative chest radiographs, such as pneumonia and pleural effusion,
- Patients with right-side heart failure or impending failure,
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 |
|---|---|---|
| lung ultrasoundThe lung ultrasound score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation). The aeration score will be built by the sum of the scores of the 12 segments, with a minimum of 0 and a maximum of 36 according to the aeration loss. | Device | Group D (Driving pressure), Group L (Lung protective strategy), Group P (Physiological PEEP) |
Primary outcome
The change in lung ultrasound score
Time frame: Periprocedural
The primary outcome will be the change in Lung Ultra Sound Score between 0 and 3 (0 = normal A lines, 1 = multiple separated B lines, 2 = coalescing B lines or light beam, 3 = consolidation) from the base line.
9 secondary outcomes
Lung compliance
Time frame: Periprocedural
Hemodynamic parameter as oxygen saturation
Time frame: Periprocedural
Hemodynamic parameter as Heart rate
Time frame: Periprocedural
Hemodynamic parameter as Mean arterial blood pressure
Time frame: Periprocedural
End-tidal carbon dioxide (ETCO2)
Time frame: Periprocedural
Plateau Pressure (Pplat)
Time frame: Periprocedural
Peak airway pressure (Ppeak)
Time frame: Periprocedural
Incidence of early postoperative pulmonary complications
Time frame: At the end of the surgery up to 24 hours after surgery
Length of post anesthesia care unit "PACU" stay.
Time frame: At the end of the surgery up to 2 hours after surgery
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 29 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 lung ultrasound in people with Obese Patients With Bariatric Surgery and Lung Ultrasound Score, run by Mahmoud Gamal Ahmed Arakeeb 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 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 Mahmoud Gamal Arakeeb, Assistant Lecturer (+201062411170, Mahmoud.arakeep@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in lung ultrasound score (time frame: Periprocedural). 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 29 Apr 2025.