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.: PACTR201708002139426 Date of Approval: 25/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title alveolar recruitment in cirrhotic patient undergoing liver resection surgery
Official scientific title The respiratory and haemodynamic effects of alveolar recruitment in cirrhotic patient undergoing liver resection surgery:
Brief summary describing the background and objectives of the trial the effect of alveolar lung recruitment maneuvers on intraoperative and post-operative lung mechanics and arterial oxygenation and intraoperative surgical blood loss, systemic haemodynamics and electric cardiometry parameters in patients undergoing hepatic resection
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied chest infection,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
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 Permuted block randomisation 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 control, tidal volume 6-8 ml/kg Fixed PEEP 5 CMH2o 20 Placebo
Experimental Group alveolar recrutment 1 30 sec optimal PEEP strstegy 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult cirrhotic liver patient (child A) scheduled for a major elective liver resection. both sex. ¿ Patients with pre-existing significant pulmonary disease. ¿ Rupture Hepatocellular carcinoma (HCC). ¿ Body-mass index higher than 40 kg/m2. ¿ Patients planned for laparoscopic hepatic resection. ¿ Refusal to participate in the study 18 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 26/03/2017 institution review board of national liver institute
Ethics Committee Address
Street address City Postal code Country
yasen abdelghfar shebin elkom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Dynamic pulmonary compliance ¿ PaO2 before each recruitment manoeuver and 20 min after. ¿ base line PaO2/FiO2 20 min after
Secondary Outcome chest infection, icu stay 1st, 3rd, 5th day postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shebin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar shebin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghafar shebin elkoom 12345 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amani Mamdouh El Sayed yassen abdelghafar shebin elkoom 12345 Egypt
Yehia H. Khater yassen abdelghafar shebin elkoom 12345 Egypt
Khaled Ahmed Yassen yassen abdelghafar shebin elkoom 12345 Egypt
Ezzeldin Saleh Ibrahim yassen abdelghafar shebin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amani Mamdouh amanimam88@gmail.com 012345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shbin elkoom 12345 Egypt resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shbin elkoom 12345 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Amani Mamdouh amanimam88@gmail.com 012345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebin elkom 12345 Egypt resident
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