Laparoscopic Bariatric SurgeriesNCT07065370
Intra-Operative Modified Ventilator Mechanical Power in Laparoscopic Bariatric Surgeries
A study of Laparoscopic Bariatric Surgeries and Hypoxemia, run by Tanta University at 1 site in Egypt.
Trial summary
To compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries. Primary outcome: Incidence of postoperative hypoxemia within the first 24 hour after surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Laparoscopic Bariatric Surgeries, Hypoxemia, Obese Patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2023to 30 Dec 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-60 years
- American society of anesthesiology physical status III
- Body mass index ≥ 40 kg/m2 undergoing laparoscopic bariatric surgery.
Who cannot join
- Uncontrolled respiratory morbidity such as sever bronchial asthma or chronic obstructive pulmonary disease.
- Patients with valvular or ischemic heart diseases, or uncontrolled hypertension
- Patients with hepatic dysfunction or renal or endocrine disorders,
- Patients with history of cerebrovascular disease or uncontrolled Diabetes mellitus.
- Previous lung surgery
- Pregnant
- Patients with neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-Operative Modified Ventilator Mechanical Power as a Predictor of Postoperative Hypoxemia In Laparoscopic Bariatric Surgeries
To compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries.
Primary outcome: Incidence of postoperative hypoxemia within the first 24 hour after surgery.
Read the detailed description
Postoperative pulmonary complications are estimated to occur in more than 30% of patients after major surgery and are associated with increased morbidity, mortality and healthcare costs. Therefore, it is desirable to identify potentially modifiable factors that may be associated with an increased risk of Postoperative pulmonary complications. A high tidal volume, a high driving pressure, and also a high flow and a high respiratory rate can induce lung injury. Changing one of these variables could inadvertently affect the other three variables .
Previous studies have focused on intraoperative lung-protective ventilation to prevent Postoperative pulmonary complications but have yielded equivocal results: the combination of lowering tidal volume and applying positive end-expiratory pressure, which resulted in lower driving pressures, improved postoperative pulmonary function and reduced major postoperative adverse events. Trials investigating single interventions were, however, nonconfirmatory: a single-center randomized controlled trial failed to demonstrate an effect of low (6 ml/kg) versus high tidal volumes (10 ml/kg) in patients undergoing surgery, .While tidal volume was the only randomized variable in these studies, there was an associated increase in respiratory rate, potentially offsetting the beneficial effect of lowering tidal volume. This illustrates the need for a unifying concept that integrates the effects of changes in multiple parameters when adjusting mechanical ventilation to reduce perioperative ventilator-induced lung injury .
Recently, it has been proposed that the extent of the ventilator-induced lung injury may relate to the amount of energy transferred from the ventilator to the lungs, a concept referred to as 'mechanical power . Measurement of mechanical power is determined by a combination of factors including tidal volume, inspiratory pressure, respiratory rate and inspiratory flow rate, all of which determine the amount of energy generated during mechanical ventilation.
Previous studies have demonstrated that mechanical power is associated with increased mortality in intensive care unit patients with and without Acute Respiratory Distress Syndrome . The effects of the intraoperative mechanical power on the occurrence of Postoperative pulmonary complications in abdominal surgery have not yet been investigated thoroughly. In our study, we hypothesized that decrease mechanical power of ventilator would decrease Postoperative pulmonary complications in patients undergoing laparoscopic bariatric surgery.
The purpose of the study to compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries
- Conditions
- Laparoscopic Bariatric Surgeries, Hypoxemia, Obese Patients
- Being tested
- Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute., Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )
- Keywords
- mechanical power, hypoxemia, morbid obese patients, laparoscopic bariatric surgeries
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.Device
Volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.
Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )Device
group received volume-controlled ventilation with tidal volume 6-8ml/kg predicted body weight with respiratory rate 18-20 cycle/minute
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute. Receives: Device: Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute. |
| Group II | Experimental | Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 18-20 cycle/minute Receives: Device: Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Measured: 24 hours postoperative
Secondary outcomes (1)
Correlation between the intraoperative mechanical power and postoperative hypoxemia
Pearson correlation test was used to assess Correlation between the intraoperative mechanical power and incidence of postoperative hypoxemia
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start30 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Bariatric SurgeriesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Ahmed Elbradey, Tanta University
- Investigators
- Ahmed Elbradey, Resident, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065370
- Sponsor's protocol ID
- 36241/12/22
- Status last verified
- Nov 2022
- First submitted
- 26 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Modified Ventilator Mechanical Power as a Predictor of Postoperative Hypoxemia In Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT07065370
- Acronym / sponsor ID
- 36241/12/22
- Conditions
- Laparoscopic Bariatric Surgeries, Hypoxemia, Obese Patients
- Keywords
- mechanical power, hypoxemia, morbid obese patients, laparoscopic bariatric surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Jul 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.
To compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries.
Primary outcome: Incidence of postoperative hypoxemia within the first 24 hour after surgery.
Detailed description
Postoperative pulmonary complications are estimated to occur in more than 30% of patients after major surgery and are associated with increased morbidity, mortality and healthcare costs. Therefore, it is desirable to identify potentially modifiable factors that may be associated with an increased risk of Postoperative pulmonary complications. A high tidal volume, a high driving pressure, and also a high flow and a high respiratory rate can induce lung injury. Changing one of these variables could inadvertently affect the other three variables .
Previous studies have focused on intraoperative lung-protective ventilation to prevent Postoperative pulmonary complications but have yielded equivocal results: the combination of lowering tidal volume and applying positive end-expiratory pressure, which resulted in lower driving pressures, improved postoperative pulmonary function and reduced major postoperative adverse events. Trials investigating single interventions were, however, nonconfirmatory: a single-center randomized controlled trial failed to demonstrate an effect of low (6 ml/kg) versus high tidal volumes (10 ml/kg) in patients undergoing surgery, .While tidal volume was the only randomized variable in these studies, there was an associated increase in respiratory rate, potentially offsetting the beneficial effect of lowering tidal volume. This illustrates the need for a unifying concept that integrates the effects of changes in multiple parameters when adjusting mechanical ventilation to reduce perioperative ventilator-induced lung injury .
Recently, it has been proposed that the extent of the ventilator-induced lung injury may relate to the amount of energy transferred from the ventilator to the lungs, a concept referred to as 'mechanical power . Measurement of mechanical power is determined by a combination of factors including tidal volume, inspiratory pressure, respiratory rate and inspiratory flow rate, all of which determine the amount of energy generated during mechanical ventilation.
Previous studies have demonstrated that mechanical power is associated with increased mortality in intensive care unit patients with and without Acute Respiratory Distress Syndrome . The effects of the intraoperative mechanical power on the occurrence of Postoperative pulmonary complications in abdominal surgery have not yet been investigated thoroughly. In our study, we hypothesized that decrease mechanical power of ventilator would decrease Postoperative pulmonary complications in patients undergoing laparoscopic bariatric surgery.
The purpose of the study to compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute. |
| Group II | Experimental | Device: Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 18-20 cycle/minute |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21-60 years
- American society of anesthesiology physical status III
- Body mass index ≥ 40 kg/m2 undergoing laparoscopic bariatric surgery.
Key exclusion criteria (7 listed)
- Uncontrolled respiratory morbidity such as sever bronchial asthma or chronic obstructive pulmonary disease.
- Patients with valvular or ischemic heart diseases, or uncontrolled hypertension
- Patients with hepatic dysfunction or renal or endocrine disorders,
- Patients with history of cerebrovascular disease or uncontrolled Diabetes mellitus.
- Previous lung surgery
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 |
|---|---|---|
| Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.Volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute. | Device | Group I |
| Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )group received volume-controlled ventilation with tidal volume 6-8ml/kg predicted body weight with respiratory rate 18-20 cycle/minute | Device | Group II |
Primary outcome
Incidence of hypoxemia
Time frame: 24 hours postoperative
1 secondary outcome
Correlation between the intraoperative mechanical power and postoperative hypoxemia
Time frame: 24 hours postoperative
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 15 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Elbradey, Resident principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Laparoscopic Bariatric Surgeries and Hypoxemia, run by Tanta 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 7 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 15 Jul 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?
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?
Incidence of hypoxemia (time frame: 24 hours postoperative). 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 15 Jul 2025.