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.: PACTR201703002110302 Date of Approval: 17/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Radial versus Dorsalis Pedis Artery cannulation for Invasive Blood Pressure Monitoring in Pediatric Laparoscopic Procedures
Official scientific title Radial versus Dorsalis Pedis Artery cannulation for Invasive Blood Pressure Monitoring in Pediatric Laparoscopic Procedures
Brief summary describing the background and objectives of the trial Background: Invasive blood pressure (IBP) monitoring is useful in critical pediatric anesthesia. Variations in IBP according to the arterial site have been studied in adults but not in pediatrics. We will evaluate the difference in IBP readings between radial artery (RA) and dorsalis pedis artery (DPA) in pediatrics and the effect of pneumoperitoneum on this difference. Methods: a monocentric prospective observational cohort of 35 children, ASA physical status I, aged 2- 6 years scheduled for laparoscopy will get both left RA and DPA cannulated and IBP measured simultaneously. We will record IBP (systolic, diastolic and mean) at both RA and DPA at six-time points (T1= before insufflation; T2= immediately after insufflation; T3= 10 min after insufflation; T4= 20 min after insufflation; T5= 30 minutes after insufflation and T6= after deflation). We wil assess the difference in IBP between radial and dorsalis pedis arteries at the different times with analysis of the effect of pneumoperitoneum on that difference.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied difference in blood pressure between radial and dorsalis pedis artery in pediatrics,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/03/2017
Actual trial start date 20/03/2017
Anticipated date of last follow up 24/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants) 35
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised children aging 2-6 years scheduled for laparoscopic surgery in supine position with ASA physical status I, will be included in the study as long the parents will agree and consent for participation and no contraindication to arterial cannulation as infection at the arterial site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group radial artery cannulation all patients included will have the radial artery cannulated operative time (after induction of general anesthesia till recovery from general anesthesia) the radial artery will be cannulated and used for measurement of invasive blood pressure, systolic, diastolic and mean pressures will be measured and recorded at different time points during the operation 35
Control Group dorsalis pedis artery cannulation all patients included will have the dorsalis pedis artery cannulated operative time (after induction of general anesthesia till recovery from general anesthesia) the dorsalis pedis artery will be cannulated and used for measurement of invasive blood pressure, systolic, diastolic and mean pressures will be measured and recorded at different time points during the operation 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age 2 to 6 years old. - ASA physical status I - Scheduled for laparoscopic surgeries in supine position. - Agreement and consenting by parents. - Positions other than supine, - Excess surgical blood loss (> 10% of estimated blood volume), - The need for inotropes or vasopressors - The presence of peripheral vascular disease or infection at the site of cannulation. - The need for inspiratory pressure more than 15 cmH2O on intra-abdominal pressure more than 8 cmH2O. - Refusal of the parents to participate 2 Year(s) 6 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 09/12/2014 Faculty of Medicine-Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Hassan Mohamed street Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison of invasive blood pressure readings between the radial artery and the dorsalis pedis artery (systolic, diastolic and mean) at both RA and DPA at six-time points (T1= before insufflation; T2= immediately after insufflation; T3= 10 min after insufflation; T4= 20 min after insufflation; T5= 30 minutes after insufflation and T6= after deflation). T1= before peritoneal insufflation. T2= immediately after peritoneal insufflation. T3= 10 min after peritoneal insufflation. T4= 20 min after peritoneal insufflation. T5= 30 minutes after peritoneal insufflation. T6= after peritoneal deflation.
Secondary Outcome complications as hematoma or vasospasm After end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University hospital Hassan Mohamed Street Beni Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni Suef University Hospital Hassan Mohamed Street Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Hospital Hassan Mohamed Street Beni Suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelaal Ahmed Mahmoud 39 mousa ebn nousir street,, 7th district, Nasr city, cairo cairo 11471 Egypt
Hazem Abdelwahab Hussein Hassan Mohamed Street Beni Suef 62511 Egypt
Ehab Mohamed Farag Hassan Mohamed Street Beni Suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelaal Ahmed Mahmoud carnitin7@yahoo.com 01113308866 39 mousa ebn nousir street,, 7th district, Nasr city, cairo
City Postal code Country Position/Affiliation
cairo 11471 Egypt Assistant Professor of Anesthesia, Faculty of Medicine, Beni-Suef University
Role Name Email Phone Street address
Public Enquiries Ehab Farag ehabmfarag@hotmail.com 00201148999983 Hassan Mohamed Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Hazem Hussein hazemwahab@yahoo.com 00201063003694 Hassan Mohamed Street
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
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