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.: PACTR202107745714528 Date of Approval: 28/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of different ventilation strategies during cardiopulmonary bypass on cardiac deairing in congenital cardiac surgery: a transesophageal echocardiography comparative study
Official scientific title Effect of different ventilation strategies during cardiopulmonary bypass on cardiac deairing in congenital cardiac surgery: a transesophageal echocardiography comparative study
Brief summary describing the background and objectives of the trial Congenital heart diseases/defects (CHD), defined as structural abnormalities of the heart or intrathoracic vessels are some of the most common congenital anomalies at birth. It is estimated that between 2 - 10 in every1,000 Live Births are affected by some type of cardiac malformation. One third of those affected have critical cardiac malformations, defined as those that require immediate investigation and surgical management. Anesthesia for Pediatric patients undergoing cardiac surgery involves anaesthetizing very small children with congenital heart disease (CHD) for major surgical procedures that require cardiopulmonary bypass (CPB). These patients require considerable expertise and in-depth knowledge of the altered physiology. There have been several developments in the last decade in this subspecialty that has contributed to better care and improved outcome. The interruption of mechanical ventilation (MV) during CPB is associated with the development of micro-atelectasis, hydrostatic pulmonary edema, reduced lung compliance and surfactant diffusion. Cardiac and pulmonary veins de-airing are of the most important steps during open heart surgery. The trapped air in heart chambers and pulmonary veins during open heart surgery is expelled in order to prevent air emboli. Air emboli can lead to cardiac arrhythmias, heart failure, cerebral complications and renal and pulmonary failure. Different techniques of de-airing have been used to both expel the air from heart chambers and prevent air emboli, including rapid shaking of the patient by the surgeon at the end of the surgery, head down position of the patient, venting of heart chambers and ascending aorta. Multiple strategies have been suggested for its prevention. These strategies may include technical modifications of cardiopulmonary bypass (CPB) (eg, ultrafiltration strategies), hemodilution, pharmacologic approaches (eg, use of steroids), and different ventilation techniques during and aftar CPB.Regarding the management of CPB time, three options are available: 1. Continuous-positive airway pressure (CPAP) with pressures between 5 and 10 cm H2O. 2. Mechanical ventilation: low tidal-low frequency ventilation (LTV). 3. Resting lung: this would seem to be the most comfortable option for the surgeon (NV) (Bignami et al., 2016).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2020
Actual trial start date 01/02/2020
Anticipated date of last follow up 30/05/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
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 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 resting lung group during CPB and 24 hour postoperative resting lng group During the surgery and CPB, the ventilator (Drager, Fabius) was turned off and the flow of fresh air was totally ceased and adjustable pressure limit (APL) valve was placed in SPONT position. 16 Active-Treatment of Control Group
Experimental Group . Continuous positive airway pressure during CPB and 24 hour postoperative During CPB, after turning the ventilator off, the flow of oxygen flow was maintained at the rate of 0.5 L/min and the APL valve was placed in MAN position on 10 mbar . 16
Experimental Group Mechanical ventilation low tidal low frequency ventilation during CPB and 24 hour postoperative Ventilator adjusted at respiratory rate of 5 acts/min with a tidal volume of 2–3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3–5 cmH2O 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All child who undergoing open heart surgery with cardiopulmonary bypass Contraindication to use TEE (previous esophageal surgery, esophageal fistula, sever coagulopathy, cervical spine disease and mediastinal radiation) Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 18 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 09/02/2020 mansoura faculty of medicine institutional review board
Ethics Committee Address
Street address City Postal code Country
2 ElGomhouria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We hypothesize that use of CPAP and LTV during CPB facilitate and improve cardiac deairing as it shortening total daairing time as primary outcome and decrease preejection and post ejection deairing time. after CPB
Secondary Outcome secondary outcome improve pulmonary outcome by decrease incidence of post operative atelectasis and postoperative pneumonia. 24 hour postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura univeristy childern hospital 2 ElGomhourya street elmansoura 35546 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed magdy 2 elgomhorya street elmansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura univeristy childern hospital 2 elgomhourya street elmansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
mohamed magdi ibrahim 2 elgomhourya street elmansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries ghada elrhamawy drghadaelrahmawy@googlemail.com +201550434587 2 elgomhouria street
City Postal code Country Position/Affiliation
elmansoura 35516 Egypt professor of anasthesia
Role Name Email Phone Street address
Principal Investigator mohamed magdy dr_mohamedmagdy1988@hotmail.com +201007388533 elgomhouria street
City Postal code Country Position/Affiliation
elmansoura Egypt assistant lecture of anasthesia
Role Name Email Phone Street address
Public Enquiries salwa mohamed salwa.hayes@yahoo.com +201002223272 elgomhouria street
City Postal code Country Position/Affiliation
elmansoura Egypt assistant professor of anasthesia
Role Name Email Phone Street address
Scientific Enquiries mohamed elgammal elgamal57elgamal@gmail.com +201002911129 elgomhouria street
City Postal code Country Position/Affiliation
elmansoura Egypt Professor of cardiothoracic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will provide individual participant data and share it through the pubmed indexed journal Informed Consent Form,Study Protocol beginning 6 mounths and ending 12 mounths following article publication we will provide individual participant data and share it through the pubmed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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