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.: PACTR202401599878859 Date of Approval: 04/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Carotid artery compression in preventing postoperative cognitive dysfunction in patients undergoing mitral valve replacement surgery: A randomized clinical trial
Official scientific title Carotid artery compression in preventing postoperative cognitive dysfunction in patients undergoing mitral valve replacement surgery: A randomized clinical trial
Brief summary describing the background and objectives of the trial Despite improvements in surgical techniques and the implementation of effective brain protection strategies, the incidence of brain injury after cardiac surgery has been relatively constant over the years. Cognitive dysfunction is the most common clinical manifestation of brain injury after cardiac surgery. Postoperative cognitive dysfunction (POCD) is the most common major neurologic complication after cardiac surgery. It is the deterioration of preoperative abilities including learning, memory, verbal skills, perception and attention, or executive capabilities; impairing patient’s quality of life and creating a social burden. It is classified into short- and long-term. Short-term POCD is transitory and lasts up to 6 weeks after surgery, and it occurs in up to 50 % of heart surgery patients. Long-term POCD is a subtle deterioration 6 months after surgery with a lower incidence (10–30%) of heart surgery patients. The etiology of POCD is multifactorial, including circulating hormone concentrations, impaired cerebral perfusion, and direct effect of anesthetics on the brain, and micro-embolic events that can occur during cardiopulmonary bypass or from aortic atherosclerosis particularly during cannulation or cross-clamping. Mini mental state examination (MMSE) is a simple test that can detect both short- and long-term cognitive function changes. Screening of short-term. Transcranial Doppler (TCD) is an innovative, flexible, accessible tool for the bedside monitoring of cerebral blood flow. This study aimed to compare patients undergoing mitral valve replacement surgery who experienced bilateral digital carotid artery compression during aortic declamping to minimize incidence of micro emboli reaching cerebral circulation with those who didn’t experience the maneuver and its association with occurrence of short term postoperative cognitive dysfunction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/07/2020
Actual trial start date 15/07/2020
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 28/02/2023
Anticipated target sample size (number of participants) 120
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral digital carotid compression For 20 seconds after aortic declamping. Bilateral digital carotid compression (for 20 seconds) was performed with three fingers (trigger, middle and ring fingers) along the course of the vessel. The carotid artery was identified guided with an ultrasound after induction of anesthesia and was marked using a non-erasable marker, then before compressing both carotid arteries their site was rechecked using ultrasound. 60
Control Group Non compression of the carotid arteries No compression of the carotid arteries was carried out No compression of the carotid arteries was carried out 60 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for mitral valve replacement surgery Patients aged 18-60 years Disturbed Conscious Level (Glasgow Coma Scale less than 15) Substance abuse MMSE score less than 24 points Emergency cases Patients unable to read and write Previous strokes or transient ischemic attacks Significant carotid artery stenosis more than 50 % Previous serious psychiatric or neurologic disorders Previous atrial fibrillation within the last 6 months Renal impairment, liver disease, or severe chronic obstructive pulmonary disease A drop in mean arterial blood pressure by more than 20% before bypass and a mean arterial blood pressure less than 60 mmHg during bypass End tidal CO2 less than 35 mmHg or more than 40 mmHg Partial pressure of oxygen less than 150 mmHg or more than 250 mmHg Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 08/07/2020 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Short-term POCD 5-7 days postoperatively
Secondary Outcome Short-term POCD 6 weeks postoperatively
Secondary Outcome Correlation of occurrence of short-term POCD with transcranial Doppler Transcranial Doppler was performed, the first reading before bypass, then every 30 minutes throughout the procedure, and the last reading after the bypass
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Alainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reham Kaddah Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aiman Desouki aiman.desouki@mail.com 00000000000000 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical Intensive care and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Reham Kaddah reham.kaddah@mail.com +201221409560 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical Intensive Care and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Reham Kaddah reham.kaddah@mail.com +201221409560 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical Intensive Care and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication Data will be available to be used for systematic reviews or meta-analyses on reasonable request directed to the corresponding author.
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