Bariatric Surgery CandidateNCT04130217
Ultrasonograpahic Evaluation of Diaphragmatic Functions in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing addition of positive end expiratory pressure in ventilated patients and addition of positive end expiratory pressure and recruitment maneuver in ventilated patients in people with Bariatric Surgery Candidate, run by Zagazig University at 1 site in Egypt.
Trial summary
Major laparoscopic sleeve gastrectomy surgery requires steep Trendelenburg position with pneumoperitoneum for a long time leading to decrease pulmonary compliance and lung volumes due to cephalic displacement and decrease excursion of the diaphragm, consequently leading to the possibility of atelectasis formation. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- addition of positive end expiratory pressure in ventilated patients and addition of positive end expiratory pressure and recruitment maneuver in ventilated patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Feb 2020
- 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
- Patient acceptance.
- Age 21-60 years old.
- BMI ≥35 kg/m2
- ASA II and ASA III.
- Elective laparoscopic sleeve gastrectomy under general anesthesia.
Who cannot join
- Preoperative diagnosis of obstructive sleep apnea by using the STOP-BANG questionnaire (Snoring, Tiredness during the daytime, observed apnea, high blood pressure, Body mass index over 35, Age, Neck circumference, and Gender)
- History of pneumothorax or right-side heart failure.
- History of chronic respiratory disease, diaphragmatic disease, or neuromuscular disease.
- Any contraindication for laparoscopic surgery or head-down position.
- Any history with post esophageal or thoracic surgeries due to intraoperative diaphragmatic manipulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Evaluation of the Effect of Recruitment Maneuvers and Positive End-expiratory Pressure on Diaphragmatic Functions and Atelectasis in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study
Major laparoscopic sleeve gastrectomy surgery requires steep Trendelenburg position with pneumoperitoneum for a long time leading to decrease pulmonary compliance and lung volumes due to cephalic displacement and decrease excursion of the diaphragm, consequently leading to the possibility of atelectasis formation. Different strategies have been proposed to reduce atelectasis and other pulmonary complications in obese patients as induction of anesthesia in the head up position with or without CPAP, protective intraoperative mechanical ventilation with high or low levels of PEEP and implementation of Recruitment Maneuvers. Up to investigators' knowledge, there is no study done to evaluate the effect of intraoperative use of PEEP and alveolar recruitment maneuver on diaphragmatic function and incidence of atelectasis via ultrasonography in obese patients undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
Bariatric surgery is one of the fastest-growing areas of surgery. It is the most effective treatment for morbid obesity and its secondary co-morbidities. Although there is no gold standard surgical procedure for obesity management, laparoscopic sleeve gastrectomy (LSG) is considered to be the first choice procedure and recently it becomes the most common bariatric surgical procedure performed worldwide. LSG is preferred to open techniques because it is associated with less incisional pain, shorter operative time, fewer pulmonary complications, and earlier hospital discharge.
However, laparoscopic procedures are operated under general anesthesia that decreases functional residual capacity (FRC) and enhances atelectasis. Also, it is performed in conjunction with intra-abdominal CO2 insufflation and subsequent increase in the intra-abdominal pressure, this CO2 pneumoperitoneum together with the steep Trendelenburg position which is maintained for long period in LSG, result in cephalic displacement of the diaphragm leading to several respiratory changes as decreased FRC and vital capacity (VC), decrease pulmonary compliance, consequently resulting in atelectasis formation in the dependent lung regions. Moreover, obese patients are more prone to develop peri-operative atelectasis and postoperative pulmonary complications that are almost twice the risk among healthy subjects.
This alteration in FRC and lung volumes are more clinically relevant as it can result in small airway closure and further ventilation-perfusion mismatch that may lead to postoperative hypoxemia and respiratory complications. Several studies revealed that these lung volumes decrease and its ensuing complications are not only due to cephalic displacement of the diaphragm but also due to decreased diaphragmatic excursion.
Several strategies have been proposed to reduce the incidence of atelectasis and other pulmonary complications such as induction of anesthesia in the head-up position with or without a continuous positive airway pressure (CPAP), use of intraoperative PEEP and implementation of alveolar recruitment maneuver (RM) but it seems that the latter may be an effective method according to several studies conducted on morbidly obese patients undergoing laparoscopic surgery and demonstrated that intraoperative recruitment of lung volume improves the respiratory mechanics and oxygenation. While other studies showed that the application of PEEP intraoperatively during laparoscopic colorectal surgery is helpful for preserving diaphragmatic excursion and consequently reduce the incidence of atelectasis.
It is worth mentioning that ultrasonography (US) can play an important role in evaluating the diaphragmatic structure by measuring diaphragmatic thickness as well as diaphragmatic function by measuring diaphragmatic excursion/displacement (DD). It is a promising bedside test to evaluate the structure and dynamic function of diaphragm peri-operatively and in critically ill patients to predict the expected outcome.
The investigators hypothesize that performing RM in addition to PEEP may have an impact on improving diaphragmatic function in terms of diaphragmatic excursion evaluated by ultrasonography in obese patients undergoing LSG. Therefore; it may decrease the incidence of postoperative pulmonary complications.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- addition of positive end expiratory pressure in ventilated patients, addition of positive end expiratory pressure and recruitment maneuver in ventilated patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
addition of positive end expiratory pressure in ventilated patientsProcedure or surgery
patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O.
addition of positive end expiratory pressure and recruitment maneuver in ventilated patientsProcedure or surgery
patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | patients will be intraoperatively mechanically ventilated without PEEP nor RM. |
| PEEP Group | Experimental | patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O. Receives: Procedure: addition of positive end expiratory pressure in ventilated patients |
| PEEP and RM Group | Experimental | patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec. Receives: Procedure: addition of positive end expiratory pressure and recruitment maneuver in ventilated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of Diaphragmatic excursion (DD)
will be measured by low frequency probe of Sonosite M Turbo ultrasonography, measurements will be taken before induction of anaesthesia, 5 min after completion of pneumoperitoneum, 5 min after adopting Trendelenburg position, 60 min later with pneumoperitoneum and Trendelenburg position, 5 min after exsufflation of pneumoperitoneum and patient placed back in the supine position, 15 min after arrival of patient in the recovery room and 24h postoperatively.
Measured: 24 hour postoperative
Secondary outcomes (1)
Incidence of lung atelectasis
atelectasis will be assessed by a linear probe of Sonosite M Turbo ultrasonography. Its measurements will be taken just before induction of anaesthesia, 15 min after arrival of the patient in the recovery room and 24h postoperatively.
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130217
- Sponsor's protocol ID
- 5610/20-1-2019
- Status last verified
- Jun 2020
- First submitted
- 14 Oct 2019
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Felsenreich DM, Prager G, Kefurt R, Eilenberg M, Jedamzik J, Beckerhinn P, Bichler C, Sperker C, Krebs M, Langer FB. Quality of Life 10 Years after Sleeve Gastrectomy: A Multicenter Study. Obes Facts. 2019;12(2):157-166. doi: 10.1159/000496296. Epub 2019 Mar 15.
PubMed 30879011Guetta O, Vakhrushev A, Dukhno O, Ovnat A, Sebbag G. New results on the safety of laparoscopic sleeve gastrectomy bariatric procedure for type 2 diabetes patients. World J Diabetes. 2019 Feb 15;10(2):78-86. doi: 10.4239/wjd.v10.i2.78.
PubMed 307880453- Sarandan M, Guragata-Balasa C, Papurica M, Duta C, Hordovan E, Rus C, et al. Anesthesia in laparoscopic bariatric surgery (gastric sleeve) - preliminary experience. TMJ 2011; 61(1): 26-31.
Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
PubMed 19809292Suh MK, Seong KW, Jung SH, Kim SS. The effect of pneumoperitoneum and Trendelenburg position on respiratory mechanics during pelviscopic surgery. Korean J Anesthesiol. 2010 Nov;59(5):329-34. doi: 10.4097/kjae.2010.59.5.329. Epub 2010 Nov 25.
PubMed 211792956- Rashwan DAE, Mahmoud HE, Nofal WH, Sabek EA. Ultrasonographic Evaluation of the Effect of Positive End-expiratory Pressure on Diaphragmatic Functions in Patients Undergoing Laparoscopic Colorectal Surgery: A Prospective Randomized Comparative Study. J Anesth Clin Res. 2018; 9(7): 843-51.
Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
PubMed 23344830
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Effect of Recruitment Maneuvers and Positive End-expiratory Pressure on Diaphragmatic Functions and Atelectasis in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04130217
- Acronym / sponsor ID
- 5610/20-1-2019
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 17 Oct 2019 (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.
Major laparoscopic sleeve gastrectomy surgery requires steep Trendelenburg position with pneumoperitoneum for a long time leading to decrease pulmonary compliance and lung volumes due to cephalic displacement and decrease excursion of the diaphragm, consequently leading to the possibility of atelectasis formation. Different strategies have been proposed to reduce atelectasis and other pulmonary complications in obese patients as induction of anesthesia in the head up position with or without CPAP, protective intraoperative mechanical ventilation with high or low levels of PEEP and implementation of Recruitment Maneuvers. Up to investigators' knowledge, there is no study done to evaluate the effect of intraoperative use of PEEP and alveolar recruitment maneuver on diaphragmatic function and incidence of atelectasis via ultrasonography in obese patients undergoing laparoscopic sleeve gastrectomy.
Detailed description
Bariatric surgery is one of the fastest-growing areas of surgery. It is the most effective treatment for morbid obesity and its secondary co-morbidities. Although there is no gold standard surgical procedure for obesity management, laparoscopic sleeve gastrectomy (LSG) is considered to be the first choice procedure and recently it becomes the most common bariatric surgical procedure performed worldwide. LSG is preferred to open techniques because it is associated with less incisional pain, shorter operative time, fewer pulmonary complications, and earlier hospital discharge.
However, laparoscopic procedures are operated under general anesthesia that decreases functional residual capacity (FRC) and enhances atelectasis. Also, it is performed in conjunction with intra-abdominal CO2 insufflation and subsequent increase in the intra-abdominal pressure, this CO2 pneumoperitoneum together with the steep Trendelenburg position which is maintained for long period in LSG, result in cephalic displacement of the diaphragm leading to several respiratory changes as decreased FRC and vital capacity (VC), decrease pulmonary compliance, consequently resulting in atelectasis formation in the dependent lung regions. Moreover, obese patients are more prone to develop peri-operative atelectasis and postoperative pulmonary complications that are almost twice the risk among healthy subjects.
This alteration in FRC and lung volumes are more clinically relevant as it can result in small airway closure and further ventilation-perfusion mismatch that may lead to postoperative hypoxemia and respiratory complications. Several studies revealed that these lung volumes decrease and its ensuing complications are not only due to cephalic displacement of the diaphragm but also due to decreased diaphragmatic excursion.
Several strategies have been proposed to reduce the incidence of atelectasis and other pulmonary complications such as induction of anesthesia in the head-up position with or without a continuous positive airway pressure (CPAP), use of intraoperative PEEP and implementation of alveolar recruitment maneuver (RM) but it seems that the latter may be an effective method according to several studies conducted on morbidly obese patients undergoing laparoscopic surgery and demonstrated that intraoperative recruitment of lung volume improves the respiratory mechanics and oxygenation. While other studies showed that the application of PEEP intraoperatively during laparoscopic colorectal surgery is helpful for preserving diaphragmatic excursion and consequently reduce the incidence of atelectasis.
It is worth mentioning that ultrasonography (US) can play an important role in evaluating the diaphragmatic structure by measuring diaphragmatic thickness as well as diaphragmatic function by measuring diaphragmatic excursion/displacement (DD). It is a promising bedside test to evaluate the structure and dynamic function of diaphragm peri-operatively and in critically ill patients to predict the expected outcome.
The investigators hypothesize that performing RM in addition to PEEP may have an impact on improving diaphragmatic function in terms of diaphragmatic excursion evaluated by ultrasonography in obese patients undergoing LSG. Therefore; it may decrease the incidence of postoperative pulmonary complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –patients will be intraoperatively mechanically ventilated without PEEP nor RM. |
| PEEP Group | Experimental | Procedure: addition of positive end expiratory pressure in ventilated patientspatients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O. |
| PEEP and RM Group | Experimental | Procedure: addition of positive end expiratory pressure and recruitment maneuver in ventilated patientspatients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- Age 21-60 years old.
- BMI ≥35 kg/m2
- ASA II and ASA III.
- Elective laparoscopic sleeve gastrectomy under general anesthesia.
Key exclusion criteria (5 listed)
- Preoperative diagnosis of obstructive sleep apnea by using the STOP-BANG questionnaire (Snoring, Tiredness during the daytime, observed apnea, high blood pressure, Body mass index over 35, Age, Neck circumference, and Gender)
- History of pneumothorax or right-side heart failure.
- History of chronic respiratory disease, diaphragmatic disease, or neuromuscular disease.
- Any contraindication for laparoscopic surgery or head-down position.
- Any history with post esophageal or thoracic surgeries due to intraoperative diaphragmatic manipulation.
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 |
|---|---|---|
| addition of positive end expiratory pressure in ventilated patientspatients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O. | Procedure or surgery | PEEP Group |
| addition of positive end expiratory pressure and recruitment maneuver in ventilated patientspatients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec. | Procedure or surgery | PEEP and RM Group |
Primary outcome
changes of Diaphragmatic excursion (DD)
Time frame: 24 hour postoperative
will be measured by low frequency probe of Sonosite M Turbo ultrasonography, measurements will be taken before induction of anaesthesia, 5 min after completion of pneumoperitoneum, 5 min after adopting Trendelenburg position, 60 min later with pneumoperitoneum and Trendelenburg position, 5 min after exsufflation of pneumoperitoneum and patient placed back in the supine position, 15 min after arrival of patient in the recovery room and 24h postoperatively.
1 secondary outcome
Incidence of lung atelectasis
Time frame: 24 hour 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 26 Jun 2020.
- Background: PubMed 30879011Felsenreich DM, Prager G, Kefurt R, Eilenberg M, Jedamzik J, Beckerhinn P, Bichler C, Sperker C, Krebs M, Langer FB. Quality of Life 10 Years after Sleeve Gastrectomy: A Multicenter Study. Obes Facts. 2019;12(2):157-166. doi: 10.1159/000496296. Epub 2019 Mar 15.
- Background: PubMed 30788045Guetta O, Vakhrushev A, Dukhno O, Ovnat A, Sebbag G. New results on the safety of laparoscopic sleeve gastrectomy bariatric procedure for type 2 diabetes patients. World J Diabetes. 2019 Feb 15;10(2):78-86. doi: 10.4239/wjd.v10.i2.78.
- Background3- Sarandan M, Guragata-Balasa C, Papurica M, Duta C, Hordovan E, Rus C, et al. Anesthesia in laparoscopic bariatric surgery (gastric sleeve) - preliminary experience. TMJ 2011; 61(1): 26-31.
- Background: PubMed 19809292Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
- Background: PubMed 21179295Suh MK, Seong KW, Jung SH, Kim SS. The effect of pneumoperitoneum and Trendelenburg position on respiratory mechanics during pelviscopic surgery. Korean J Anesthesiol. 2010 Nov;59(5):329-34. doi: 10.4097/kjae.2010.59.5.329. Epub 2010 Nov 25.
- Background6- Rashwan DAE, Mahmoud HE, Nofal WH, Sabek EA. Ultrasonographic Evaluation of the Effect of Positive End-expiratory Pressure on Diaphragmatic Functions in Patients Undergoing Laparoscopic Colorectal Surgery: A Prospective Randomized Comparative Study. J Anesth Clin Res. 2018; 9(7): 843-51.
- Background: PubMed 23344830Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing addition of positive end expiratory pressure in ventilated patients and addition of positive end expiratory pressure and recruitment maneuver in ventilated patients in people with Bariatric Surgery Candidate, run by Zagazig 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: finished, as of the sponsor's last update on 26 Jun 2020. 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?
changes of Diaphragmatic excursion (DD) (time frame: 24 hour postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130217, which also lists 7 linked publications.
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 26 Jun 2020.