Bariatric SurgeryNCT06000969
Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery
A study testing Lung Recruitment Conventional and Lung Recruitment Ultrasound in people with Bariatric Surgery and Obesity, Morbid, run by Tanta University at 2 sites in Egypt.
Trial summary
Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis. Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bariatric Surgery, Obesity, Morbid
- What is being tested?
- Lung Recruitment Conventional and Lung Recruitment Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesEgypt
- Study dates
- 14 Aug 2023to 1 Nov 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic bariatric surgery
Who cannot join
- Patient refusal
- Patients with history of severe obstructive or restrictive pulmonary disease.
- Patients with severe obstructive sleep apnea (OSA).
- Presence of emphysematous lung bullae.
- Decompensated cardiac disease (NYHA class 3 or 4).
- Patients with uncontrolled hepatic or renal disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Tanta University
Tanta, Algharbia, 31511
Tanta University hospitals
Tanta, 31511
About this study
Official title: Conventional Versus Ultrasound-guided Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery: Prospective Randomized Clinical Study
Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis.
Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the effects of lung recruitment manoeuvres.
Read more
This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of intraoperative\& postoperative oxygen desaturation, and reduce the incidence of post operative pulmonary complications.
The aim of this prospective randomized clinical study is to compare the conventional recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients scheduled for laparoscopic bariatric surgery.
Read the detailed description
- This prospective randomized clinical double-blinded study will be carried out at Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to August 2024 after approval from our institutional ethical committee. All enrolled patients will sign an informed written consent to participate in the study.
- Every patient will receive an explanation of the purpose of the study and have secret code number to ensure privacy and confidentiality, all given data will be used for scientific purposes only.
- Any unexpected risks encountered during the research will be cleared to the participants, as well as to the Ethical Committee on time. The risk at the study includes increased risk of bradycardia and hypotension that will be managed by adequate monitoring, atropine, IV fluids, and ephedrine.
-Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :-
- Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
- Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
-Anesthesia technique
I-Preoperative assessment:
▪ All patients will be assessed preoperatively at the Anesthesia Clinic through history, physical examination and requesting the appropriate investigations.
II-In the Holding Area:
- Patient counselling regarding anesthesia technique and surgery.
- Secured IV line.
III- In the Operation Room:
- Standard Monitoring: On arrival of the patient to the operating theater and before induction of anesthesia, all standard monitors will be applied, including heart rate (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, non-invasive blood pressure, and temperature.
- Induction of anesthesia: all patients will be pre-oxygenated with 80% oxygen for 3 minutes before induction. Anesthesia will be induced by slowly titrating doses of intravenous fentanyl (2 ug/kg of lean body weight) and propofol (1 mg/kg of lean body weight). Intubation will be facilitated with atracurium (0.5 mg/kg of lean body weight). Anesthesia will be maintained with atracurium, isoflurane of 1 MAC and fraction inspired Oxygen of 0.5 for each patient.
- Mechanical ventilation protocol: patients will receive the standard ventilation protocol as follows: volume-controlled ventilation mode, with a tidal volume of 4-6 mL/kg of predicted body weight, inspiratory: expiratory ratio 1: 2, PEEP 5 cmH2O, initial respiratory rate is 12/m then adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35- and 40-mm Hg, and inspired oxygen fraction of 0.5 with total gas flow 1L/m. The patients and investigators who will be responsible for assessing the primary outcomes will be blinded to study group assignment. However, the attending anesthesiologists, intraoperative nursing staff, and intraoperative assessors will not be blinded to study group assignment.
- Positioning and pneumoperitoneum: the patients will be put in reverse trendelenburg position, 30°C head-up position slowly, the position will be kept until the end of surgery.
Intraabdominal pressure will be maintained between 12 ± 3 cmH2O during surgery.
▪ Lung ultrasound examination: will be done: After the induction of anaesthesia (time point T1). After pneumoperitoneum (time point T2). At the end of surgery (before administrating reversal agents for neuromuscular blockade; (time point T3).
- Lung recruitment: recruitment maneuver will be performed in each group as described before after every intraoperative lung ultrasound examination. Intra-abdominal pressure will be recorded. If hypotension (MAP<65mmhg), bradycardia (heart rate<50/m.) or oxygen desaturation (spO2<95%) has been occurred, rescue strategy will be applied as described later.
- Rescue strategy for oxygen desaturation: In both groups, when SpO2 decreased to 95% or lower, the following rescue ventilation strategies will be performed in a stepwise manner (i.e., if SpO2 did not increase after a step, then the following step was applied; otherwise, no further steps were applied).
Steps were performed according to the following order:
- Step (1), three rounds of recruitment maneuvers with a pressure of 30 cmH2O for 10 s.
- Step (2), three rounds of recruitment maneuvers with a pressure of 35 cmH2O for 10 s.
- Step (3), increase FIO2 to 1.0. If SpO2 did not increase after all three rescue strategies, the ventilation strategies could be modified according to the attending anesthesiologist's judgement.
- Conditions
- Bariatric Surgery, Obesity, Morbid
- Being tested
- Lung Recruitment Conventional, Lung Recruitment Ultrasound
- Keywords
- Morbidly obese, Bariatric surgery, Lung recruitment
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Recruitment ConventionalDevice
the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
Lung Recruitment UltrasoundDevice
the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group (group C) | Experimental | Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds. Receives: Device: Lung Recruitment Conventional |
| Ultrasound-guided group (group US) | Experimental | Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed. Receives: Device: Lung Recruitment Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Lung Ultrasound Score
Assessment of the changes in the lung ultrasound score
Measured: 2 hours
Secondary outcomes (2)
The incidence of atelectasis
defined as LUS of ≥ 2 for any of the 12 regions
Measured: 2 hours
The incidence of intra-operative desaturation
defined as an SpO2 <95%
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start14 Aug 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :- * Conventional group (group C); 30 patients: * Ultrasound-guided group (group US); 30 patients:
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Principal investigator, Assistant Professor of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000969
- Sponsor's protocol ID
- 36264MD12
- Status last verified
- Nov 2024
- First submitted
- 11 Aug 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available with the principle investigator within 6 months after publishing the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Ultrasound-guided Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery: Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06000969
- Acronym / sponsor ID
- 36264MD12
- Conditions
- Bariatric Surgery, Obesity, Morbid
- Keywords
- Morbidly obese, Bariatric surgery, Lung recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Aug 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.
Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative technique that has been widely used in clinical monitoring and diagnosis.
Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the effects of lung recruitment manoeuvres.
This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of intraoperative\& postoperative oxygen desaturation, and reduce the incidence of post operative pulmonary complications.
The aim of this prospective randomized clinical study is to compare the conventional recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients scheduled for laparoscopic bariatric surgery.
Detailed description
- This prospective randomized clinical double-blinded study will be carried out at Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to August 2024 after approval from our institutional ethical committee. All enrolled patients will sign an informed written consent to participate in the study.
- Every patient will receive an explanation of the purpose of the study and have secret code number to ensure privacy and confidentiality, all given data will be used for scientific purposes only.
- Any unexpected risks encountered during the research will be cleared to the participants, as well as to the Ethical Committee on time. The risk at the study includes increased risk of bradycardia and hypotension that will be managed by adequate monitoring, atropine, IV fluids, and ephedrine.
-Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :-
- Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
- Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
-Anesthesia technique
I-Preoperative assessment:
▪ All patients will be assessed preoperatively at the Anesthesia Clinic through history, physical examination and requesting the appropriate investigations.
II-In the Holding Area:
- Patient counselling regarding anesthesia technique and surgery.
- Secured IV line.
III- In the Operation Room:
- Standard Monitoring: On arrival of the patient to the operating theater and before induction of anesthesia, all standard monitors will be applied, including heart rate (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, non-invasive blood pressure, and temperature.
- Induction of anesthesia: all patients will be pre-oxygenated with 80% oxygen for 3 minutes before induction. Anesthesia will be induced by slowly titrating doses of intravenous fentanyl (2 ug/kg of lean body weight) and propofol (1 mg/kg of lean body weight). Intubation will be facilitated with atracurium (0.5 mg/kg of lean body weight). Anesthesia will be maintained with atracurium, isoflurane of 1 MAC and fraction inspired Oxygen of 0.5 for each patient.
- Mechanical ventilation protocol: patients will receive the standard ventilation protocol as follows: volume-controlled ventilation mode, with a tidal volume of 4-6 mL/kg of predicted body weight, inspiratory: expiratory ratio 1: 2, PEEP 5 cmH2O, initial respiratory rate is 12/m then adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35- and 40-mm Hg, and inspired oxygen fraction of 0.5 with total gas flow 1L/m. The patients and investigators who will be responsible for assessing the primary outcomes will be blinded to study group assignment. However, the attending anesthesiologists, intraoperative nursing staff, and intraoperative assessors will not be blinded to study group assignment.
- Positioning and pneumoperitoneum: the patients will be put in reverse trendelenburg position, 30°C head-up position slowly, the position will be kept until the end of surgery.
Intraabdominal pressure will be maintained between 12 ± 3 cmH2O during surgery.
▪ Lung ultrasound examination: will be done: After the induction of anaesthesia (time point T1). After pneumoperitoneum (time point T2). At the end of surgery (before administrating reversal agents for neuromuscular blockade; (time point T3).
- Lung recruitment: recruitment maneuver will be performed in each group as described before after every intraoperative lung ultrasound examination. Intra-abdominal pressure will be recorded. If hypotension (MAP<65mmhg), bradycardia (heart rate<50/m.) or oxygen desaturation (spO2<95%) has been occurred, rescue strategy will be applied as described later.
- Rescue strategy for oxygen desaturation: In both groups, when SpO2 decreased to 95% or lower, the following rescue ventilation strategies will be performed in a stepwise manner (i.e., if SpO2 did not increase after a step, then the following step was applied; otherwise, no further steps were applied).
Steps were performed according to the following order:
- Step (1), three rounds of recruitment maneuvers with a pressure of 30 cmH2O for 10 s.
- Step (2), three rounds of recruitment maneuvers with a pressure of 35 cmH2O for 10 s.
- Step (3), increase FIO2 to 1.0. If SpO2 did not increase after all three rescue strategies, the ventilation strategies could be modified according to the attending anesthesiologist's judgement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :- * Conventional group (group C); 30 patients: * Ultrasound-guided group (group US); 30 patients:
| Arm | Type | Receives |
|---|---|---|
| Conventional group (group C) | Experimental | Device: Lung Recruitment ConventionalPatients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds. |
| Ultrasound-guided group (group US) | Experimental | Device: Lung Recruitment UltrasoundPatients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic bariatric surgery
Key exclusion criteria (6 listed)
- Patient refusal
- Patients with history of severe obstructive or restrictive pulmonary disease.
- Patients with severe obstructive sleep apnea (OSA).
- Presence of emphysematous lung bullae.
- Decompensated cardiac disease (NYHA class 3 or 4).
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 Recruitment Conventionalthe recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds. | Device | Conventional group (group C) |
| Lung Recruitment Ultrasoundthe recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed. | Device | Ultrasound-guided group (group US) |
Primary outcome
the change of Lung Ultrasound Score
Time frame: 2 hours
Assessment of the changes in the lung ultrasound score
2 secondary outcomes
The incidence of atelectasis
Time frame: 2 hours
The incidence of intra-operative desaturation
Time frame: 3 hours
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 3 Dec 2024.
- Individual participant dataSharing planned: Yes. The IPD will be available with the principle investigator within 6 months after publishing the study.
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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.
Sameh Ismaiel, M.D principal investigator
Assistant Professor of Anesthesia and Intensive Care, Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Recruitment Conventional and Lung Recruitment Ultrasound in people with Bariatric Surgery and Obesity, Morbid, run by Tanta University at 2 sites 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 1 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
the change of Lung Ultrasound Score (time frame: 2 hours). 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 3 Dec 2024.