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.: PACTR201802003138123 Date of Approval: 22/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of inspired oxygen concentration on postoperative pulmonary atelectasis in obese patients undergoing laparoscopic cholecystectomy. A random
Official scientific title The effect of inspired oxygen concentration on postoperative pulmonary atelectasis in obese patients undergoing laparoscopic cholecystectomy. A randomized-controlled double-blind study
Brief summary describing the background and objectives of the trial Background: Atelectasis is the most important postoperative pulmonary complication in obese patients following general anaesthesia. Objectives: To study the effect of inspired high versus low oxygen concentration on pulmonary atelectasis in obese patients undergoing laparoscopic cholecystectomy during general anaesthesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,anesthesia,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/06/2017
Actual trial start date 25/06/2017
Anticipated date of last follow up 15/02/2018
Actual Last follow-up date 04/02/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group oxygen 90% oxygen during anesthesia,2 h postoperative oxygen 90% 30 Active-Treatment of Control Group
Experimental Group oxygen 40% oxygen during anesthesia, 2 h postoperative xygen 40% 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II, of both sexes, aged 20-60 years, and BMI < 30 kg/m2 scheduled for elective laparoscopic cholecystectomy patient refusal to be included in the study, history of current symptoms of acute or chronic pulmonary disease, history of current symptoms of cardiac disease, fever or infection and patients who need open cholecystectomy because of a surgical cause 20 Year(s) 60 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 18/06/2017 anesthesia department,faculty of medicine,menoufiya university
Ethics Committee Address
Street address City Postal code Country
3, yassin abd elghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pulmonary atelectasis determined by CT scan 24 hours after the end of surgery
Secondary Outcome pulmonary atelectasis determined by X-ray 24 hours after the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya faculty of medicine hospital 3, yassin abd elghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ashraf eskandr 3, yassin abd elghafar street shibin elkoom 12345 Egypt
hatem atallah 3, yassin abd elghafar street shibin elkoom 12345 Egypt
sadik a sadik 3, yassin abd elghafar street shibin elkoom 12345 Egypt
mahmoud mohammed boor said aga 2345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abd-elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt assistant professor,menoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries mahmoud mohammed mahmsaad@yahoo.com 00201004986145 bour said
City Postal code Country Position/Affiliation
aga 2345 Egypt
Role Name Email Phone Street address
Scientific Enquiries hatem attalah hatattalla@hotmail.com 00201001445568 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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