Bariatric Surgery CandidateNCT06494410
Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment
A study testing High versus Low Fraction of Inspired Oxygen in people with Bariatric Surgery Candidate and Atelectasis, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury. The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Atelectasis
- What is being tested?
- High versus Low Fraction of Inspired Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2023to 10 Jul 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 - 60 years old.
- Both genders.
- Preoperative Physical Status: ASA II, III Patients.
- BMI above 40 Kg/m2.
- Patients undergoing laparoscopic bariatric surgeries: laparoscopic mini gastric bypass, Roux-en-Y gastric bypass and revision bariatric surgery (redo bariatric surgery) with the presence of atelectasis confirmed radiologically by Chest X-ray (CXR) and CT Chest
Who cannot join
- Refusal of the intervention or participation in the study.
- Patient under age of 18 years old or above 60 years old.
- Preoperative Physical Status: ASA I, IV.
- Psychiatric illness.
- Known cases of chronic pulmonary disease e.g. COPD and bronchial asthma.
- Known cases of cardiac diseases.
- Previous lung surgery.
- Lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment on Absorption Atelectasis in Laparoscopic Bariatric Surgery Patients With Atelectasis
Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury.
The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment.
During general anesthesia, absorption atelectasis reportedly occurs in most patients especially during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance
Read the detailed description
The incidence of obesity (defined by a body mass index (BMI) > 30 kg/m2) is increasing worldwide. In selected individuals, bariatric surgery may offer means of achieving long-term weight loss, improved health, and healthcare cost reduction. Physiological changes that occur because of obesity and general anesthesia predispose to respiratory complications following bariatric surgery.
Obesity affects many respiratory functions, including, among others, a reduction in functional residual capacity, an increase in airway resistance, and a high level of ventilation-perfusion mismatch. The combination of obesity and postoperative respiratory muscle dysfunction could promote respiratory failure.
Absorption atelectasis occurs in most patients, typically due to absorption of gas, compression of the lung tissue, and impairment of surfactant function. Additionally, during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance.
Compression of basal lung regions due to a stiffened diaphragm would accelerate the formation of absorption atelectasis that was already initiated during anesthesia induction.
Such deterioration is associated with pulmonary densities revealed by computed tomography. In addition to physiologic impairment, atelectasis could contribute to perioperative lung injury and PPC.
The RM with PEEP has been advocated as efficient for atelectasis treatment. Reports on the impact of FiO2 during RM on atelectasis development are rare, and have not limited FiO2 to the RM per se.
While RM with high FiO2 can improve oxygenation rapidly, there is a greater possibility of absorption atelectasis occurring.
Diagnostic ultrasonography is the only clinical imaging technology in use that does not depend on electromagnetic radiation. Lung ultrasonography can be considered an attractive complementary diagnostic tool and one of the most promising techniques (Daabis et al., 2014). Therefore, Lung ultrasonography is a safe and cheap tool used during the perioperative period and to detect intraoperative respiratory complications resulting from absorption atelectasis.
The modified Lung Ultrasound Score (LUSS) system involves examination of all intercostal spaces: each hemi-thorax is divided into six regions: 2 anterior, 2 lateral and 2 posterior with four longitudinal lines and one axial line [figure 1 (B, C)]. Each region score shows sufficient sensitivity to detect loss of aeration during laparoscopic surgery. The degree of de-aeration rated from 0 to 3 (zero for no atelectasis and 3 for complete atelectasis ) defining substantial atelectasis as a score of 2 or 3 assigned to any region
- Conditions
- Bariatric Surgery Candidate, Atelectasis
- Being tested
- High versus Low Fraction of Inspired Oxygen
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High versus Low Fraction of Inspired OxygenProcedure or surgery
to compare the effect of high oxygen fraction (FiO2 1.0) vs. low oxygen fraction (FiO2 0.4) on clinical outcome on intraoperative and postoperative atelectasis and PPC. We will asses the impact of FiO2, especially during RM, on atelectasis development, using modified LUSS in obese patients with atelectasis undergoing laparoscopic bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| High Fraction of Inspired Oxygen(Group A) | Active comparator | About 40 patients received FiO2 1.0 during recruitment maneuvers Receives: Procedure: High versus Low Fraction of Inspired Oxygen |
| Low Fraction of Inspired Oxygen(Group B) | Active comparator | About 40 patients received FiO2 0.4 during recruitment maneuvers Receives: Procedure: High versus Low Fraction of Inspired Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Lung Ultrasound Score (LUSS)
- Modified LUSS at surgery completion compared to baseline preoperative modified LUSS, reflecting any aeration loss during general anesthesia.
Measured: from 0 hours to 6 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start7 Feb 2023
- Primary completion7 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor
- Investigators
- Madiha Metwaly Zidan, Professor, Study chair, Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, EgyptAhmed Ali Fawaz, Professor, Study director, Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494410
- Sponsor's protocol ID
- Abdallah Adel Saber
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment on Absorption Atelectasis in Laparoscopic Bariatric Surgery Patients With Atelectasis
- ClinicalTrials.gov ID
- NCT06494410
- Acronym / sponsor ID
- Abdallah Adel Saber
- Conditions
- Bariatric Surgery Candidate, Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Ain Shams University
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 10 Jul 2024 (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.
Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury.
The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment.
During general anesthesia, absorption atelectasis reportedly occurs in most patients especially during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance
Detailed description
The incidence of obesity (defined by a body mass index (BMI) > 30 kg/m2) is increasing worldwide. In selected individuals, bariatric surgery may offer means of achieving long-term weight loss, improved health, and healthcare cost reduction. Physiological changes that occur because of obesity and general anesthesia predispose to respiratory complications following bariatric surgery.
Obesity affects many respiratory functions, including, among others, a reduction in functional residual capacity, an increase in airway resistance, and a high level of ventilation-perfusion mismatch. The combination of obesity and postoperative respiratory muscle dysfunction could promote respiratory failure.
Absorption atelectasis occurs in most patients, typically due to absorption of gas, compression of the lung tissue, and impairment of surfactant function. Additionally, during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance.
Compression of basal lung regions due to a stiffened diaphragm would accelerate the formation of absorption atelectasis that was already initiated during anesthesia induction.
Such deterioration is associated with pulmonary densities revealed by computed tomography. In addition to physiologic impairment, atelectasis could contribute to perioperative lung injury and PPC.
The RM with PEEP has been advocated as efficient for atelectasis treatment. Reports on the impact of FiO2 during RM on atelectasis development are rare, and have not limited FiO2 to the RM per se.
While RM with high FiO2 can improve oxygenation rapidly, there is a greater possibility of absorption atelectasis occurring.
Diagnostic ultrasonography is the only clinical imaging technology in use that does not depend on electromagnetic radiation. Lung ultrasonography can be considered an attractive complementary diagnostic tool and one of the most promising techniques (Daabis et al., 2014). Therefore, Lung ultrasonography is a safe and cheap tool used during the perioperative period and to detect intraoperative respiratory complications resulting from absorption atelectasis.
The modified Lung Ultrasound Score (LUSS) system involves examination of all intercostal spaces: each hemi-thorax is divided into six regions: 2 anterior, 2 lateral and 2 posterior with four longitudinal lines and one axial line [figure 1 (B, C)]. Each region score shows sufficient sensitivity to detect loss of aeration during laparoscopic surgery. The degree of de-aeration rated from 0 to 3 (zero for no atelectasis and 3 for complete atelectasis ) defining substantial atelectasis as a score of 2 or 3 assigned to any region
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Fraction of Inspired Oxygen(Group A) | Active comparator | Procedure: High versus Low Fraction of Inspired OxygenAbout 40 patients received FiO2 1.0 during recruitment maneuvers |
| Low Fraction of Inspired Oxygen(Group B) | Active comparator | Procedure: High versus Low Fraction of Inspired OxygenAbout 40 patients received FiO2 0.4 during recruitment maneuvers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged between 18 - 60 years old.
- Both genders.
- Preoperative Physical Status: ASA II, III Patients.
- BMI above 40 Kg/m2.
- Patients undergoing laparoscopic bariatric surgeries: laparoscopic mini gastric bypass, Roux-en-Y gastric bypass and revision bariatric surgery (redo bariatric surgery) with the presence of atelectasis confirmed radiologically by Chest X-ray (CXR) and CT Chest
Key exclusion criteria (8 listed)
- Refusal of the intervention or participation in the study.
- Patient under age of 18 years old or above 60 years old.
- Preoperative Physical Status: ASA I, IV.
- Psychiatric illness.
- Known cases of chronic pulmonary disease e.g. COPD and bronchial asthma.
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 |
|---|---|---|
| High versus Low Fraction of Inspired Oxygento compare the effect of high oxygen fraction (FiO2 1.0) vs. low oxygen fraction (FiO2 0.4) on clinical outcome on intraoperative and postoperative atelectasis and PPC. We will asses the impact of FiO2, especially during RM, on atelectasis development, using modified LUSS in obese patients with atelectasis undergoing laparoscopic bariatric surgery. | Procedure or surgery | High Fraction of Inspired Oxygen(Group A), Low Fraction of Inspired Oxygen(Group B) |
Primary outcome
Modified Lung Ultrasound Score (LUSS)
Time frame: from 0 hours to 6 hours after the procedure
1. Modified LUSS at surgery completion compared to baseline preoperative modified LUSS, reflecting any aeration loss during general anesthesia.
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 2024.
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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.
Madiha Metwaly Zidan, Professor study chair
Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, Egypt
Ahmed Ali Fawaz, Professor study director
Department of Anesthesia and I.C.U. faculty of Medicine,Ain Shams university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High versus Low Fraction of Inspired Oxygen in people with Bariatric Surgery Candidate and Atelectasis, run by Egymedicalpedia 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 8 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 2024. 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?
Modified Lung Ultrasound Score (LUSS) (time frame: from 0 hours to 6 hours after the procedure). 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 2024.