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.: PACTR202103499307292 Date of Approval: 26/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Inverse ratio ventilation on hemodynamics and respiratory mechanics in obese patients undergoing laparoscopic sleeve gastrectomy.
Official scientific title Effect of Inverse ratio ventilation on hemodynamics and respiratory mechanics in obese patients undergoing laparoscopic sleeve gastrectomy.
Brief summary describing the background and objectives of the trial Ventilation with a prolonged inspiratory to expiratory ratio (I:E ratio) has become an alternative strategy for improving respiratory mechanics. This strategy is used not only in critical patients with acute respiratory distress syndrome but also in surgical patients with reduced lung compliance due to surgical factors. We hypothesized that a prolonged I:E ratio of 2:1 would improve respiratory mechanics without reducing cardiac output during pneumoperitoneium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2018
Actual trial start date 01/04/2019
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL
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 Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group inverse ratio ventilation group volume control ventilation with inverse ration 2:1 intraoperative period Ventilation parameters were set as: tidal volume 8 mL/kg ideal body weight, respiratory rate 12 breaths/min, zero PEEP, fraction inspired oxygen (FiO2) 0.6, oxygen flow 2 L/min, inspiratory pause 10%, and I:E ratio of 2:1 26
Control Group volume control ventilation with normal ratio I:E ratio of 1:2 intraoperative period Ventilation parameters were set as: tidal volume 8 mL/kg ideal body weight, respiratory rate 12 breaths/min, zero PEEP, fraction inspired oxygen (FiO2) 0.6, oxygen flow 2 L/min, inspiratory pause 10%, and I:E ratio of 1:2 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.morbidly obese patients 2.for laparoscopic sleeve gastrectomy in reverse Trendelenburg position 3.from 21-45 years old, 4.ranging BMI between 35-50 kg/m2, 5.ASA II and III. 1.patients with age more than 45 years and less than 21 years 2. BMI higher than 50kg/m2, 3. ASA class IV, severe intraoperative bleeding affecting hemodynamics, 4.operations that extended more than 60 minutes Adult: 19 Year-44 Year 21 Year(s) 45 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 21/03/2019 Ain Shams University Faculty of medicine Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome volume-controlled inverse ratio ventilation (IRV) with inspiratory to expiratory (I:E) ratio of 2:1 could improve oxygenation as a primary outcome Lung mechanics readings including peak pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean) were recorded every 10 minutes till end of the first hour, also dynamic and static compliance of the respiratory system were calculated after intubation and every 10 minutes until the end of the first hour. Static compliance = tidal volume /Pplateau-PEEP and Dynamic compliance= tidal volume/Ppeak-Peep intraoperative period
Secondary Outcome Hemodynamic parameters; Mean arterial blood pressure (MAP) heart rate (HR) were monitored at the start and all through the procedure and recorded before anesthesia induction (T0), immediately after intubation (T1), before pneumoperitoneum (T2), after pneumoperitoneum(T3) and then every 10 minutes till 60 minutes. intraoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University abbassia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amgad serag eldeen sayed mohamed elkholy 362 zahraa madinet nasr Cairo 11377 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University Abbassia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Noha Hussein sayed abbasia cairo 11591 Egypt
Dr. Mohamed saeed Abd Elaziz abbasia cairo 11591 Egypt
Dr. Mohamed Osman Taeimah abbasia cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amgad serag dr_serag88@hotmail.com 00201014747227 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries mohammed saeed mohdsaeed47@yahoo.com 00201002209759 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries mohammed Taeimah taeimah@me.com 00201003080938 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol and results will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/03/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information