Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205833785538 Date of Registration: 04/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lung Ultrasound Guided Positive End Expiratory Pressure Adjustment in Enhanced Recovery Program Based Laparoscopic Bariatric Surgery
Official scientific title Lung Ultrasound Guided Positive End Expiratory Pressure Adjustment in Enhanced Recovery Program Based Laparoscopic Bariatric Surgery
Brief summary describing the background and objectives of the trial Obesity is a major health problem with clearly established health implications. Bariatric surgery as a method of treatment has become an established and renowned therapy for the management of patients with morbid obesity. Obese patients have an increased risk of postoperative atelectasis and respiratory function impairment especially after procedures under general anaesthesia. Enhanced recovery after bariatric surgery or Ultra-Fast Track pathway indicates a multidisciplinary strategy to enhance postoperative recovery and decrease morbidity by reducing surgical stress and its consequences. Protective lung strategy has been described and used in critically ill patients; it showed favorable outcomes when applied during general anesthesia. The use of positive end expiratory pressure (PEEP) is a basic component of protective lung strategy. Several studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques or by using electrical impedance tomography. Lung ultrasound is a bedside economic technique that is gaining interest in the operating room. We suppose that with the ultrasound-guided PEEP approach, incidence of intraoperative and early postoperative hypoxia and atelectasis could be reduced.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Morbid obesity
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/05/2022
Actual trial start date
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound N/A Preoperative Intraoperative postoperative lung ultrasound adjusted stepwise intraoperative positive end expiratory pressure (PEEP) 25
Control Group Standard N/A Preoperative Intraoperative postoperative Patients will be subjected to intraoperative PEEP 5 cmH2O. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for laparoscopic bariatric surgery under general anaesthesia and applying perioperative enhanced recovery protocol.(Body mass index (BMI)≥ 35kg/m2 ASA score > III. Diabetic patients. Presence of lung bullae Patient with history of asthma, COPD or any other chronic respiratory disease. Patients with known hypersensitivity or contraindication to medications used in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/09/2021 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Arterial Oxygen Tension (PaO2) Baseline before induction of anaesthesia Intraoperative 5 min after initiation 5 min after pneumoperitoneum 5 min after every PEEP increase
Secondary Outcome Heart rate Preoperative Intraoperative 5 min after initiation 5 min after pneumoperitoneum 5 min after every PEEP increase
Secondary Outcome Mean arterial blood pressure Preoperative Intraoperative 5 min after initiation 5 min after pneumoperitoneum 5 min after every PEEP increase
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery Department Faculty of Medicine Alexanderia Uneversity 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hossameldin Ibrahim Mahmoud Negm 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria University 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wafaa Mohamed Shafshak 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Ola MohyEldin Zanaty 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Hisham Mohamed Gamal Eldine Hassan 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Hossameldin Ibrahim Mahmoud Negm 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wafaa Shafshak shafshak_waf@yahoo.com 00201005264390 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Hisham GamalEldine Hesham.gamal@alexmed.edu.eg 00201006665018 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecture of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information