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.: PACTR201705002291178 Date of Approval: 12/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasonographic assessment of lung protection during cardiac surgery
Official scientific title Ultrasonographic assessment of the effect of intermittent lung recruitment during cardiopulmonary bypass in valvular cardiac surgeries
Brief summary describing the background and objectives of the trial Background and Rationale : Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with cardiopulmonary bypass( CPB). We will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW). Objectives : To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on: Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied acute lung injury,Injury, Occupational Diseases, Poisoning,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/06/2017
Actual trial start date
Anticipated date of last follow up 10/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group nothing During bypass, patients in this group will not receive any lung recruitment 30
Experimental Group Lung protection every 30-40 minutes 30 seconds during bypass intemittent lung recruitment at preesure 35 cmH2O followed by PEEP of 5 cmH2O 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
elective valvular cardiac surgery with cardiopulmonary bypass (CPB). ¿ Emergency surgeries. ¿ coronary artery bypass graft surgery ¿ patients requiring re-exploration in the immediate postoperative period (within 2hours) ¿ left Ventricular ejection fraction less than 40% ¿ patients with preoperative congestive heart failure, cardiogenic shock , preoperative pulmonary edema ¿ pre-existing severe chronic pulmonary dysfunction (defined as pulmonary disease requiring home oxygen therapy or causing shortness of breath after 1 to 2 flights of stairs) ¿ Morbid obesity ¿ Renally impaired patients with creatinine more than 2 mg/dl 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 26/11/2016 Research Ethics Committee(REC),faculty of medicine ,cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy St. Cairo, Egypt Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ The change of Lung ultrasound score LUS from the baseline values for assessment of extra vascular lung water 1) in the operating room before induction of anesthesia (baseline), 2) immediately at the end of operation, 3) 2 hours after ICU admission:
Secondary Outcome ¿ Oxygenation (po2),oxygenation index (po2/fio2) ¿ Time for extubation ¿ Length of ICU stay 1) in the operating room before induction of anesthesia (baseline), 2) immediately at the end of operation, 3) 2 hours after ICU admission:
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic surgery operating theatre, KasrAlaini hospital, Cairo University. Kasr Al Ainy St. Cairo, Egypt Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr alaini hospital .faculty of medicine ,cairouniversity Kasr Al Ainy St. Cairo, Egypt Cairo 11562 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Anesthesia department,faculty of medicine ,cairo university Kasr Al Ainy St. Cairo, Egypt Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maged El-gendy magedabdelwahab@yahoo.com 201003620361 4 abrag rhmania st Mariotia Faisl
City Postal code Country Position/Affiliation
Giza Egypt Anesthesia department, faculty of medicine ,cairo university
Role Name Email Phone Street address
Principal Investigator Ahmed El-Agaty aelagaty@hotmail.com 201007022284 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Giza Egypt prof of anesthesiology ,faculty of medicine .cairo university
Role Name Email Phone Street address
Public Enquiries Mohammed Hamza Mkhamza@hotmail.com 01006686834 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Tareq Maraei taamarei@gmail.com 01001018888 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of anesthesiology
REPORTING
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Result URL Hyperlinks
Changes to trial information