Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771935
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-03-05
Brief Title:
Ultrasound Guided Ulnar Versus Radial Artery in Pediatrics Undergoing Major Non Cardiac Surgery
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
Ultrasound Guided Ulnar Versus Radial Artery Cannulation in Pediatrics Undergoing Major Non Cardiac Surgery Double Blinded Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess the safety and efficacy of ulnar artery cannulation compared to radial artery cannulation in pediatrics undergoing major non cardiac procedures
Detailed Description:
The study is a double blinded randomized controlled trial that will be conducted at Abu Al Reesh Childrens Hospital Faculty of Medicine Cairo University after approval of research and ethics committees
Children will be recruited into the trial during pre-operative assessment will be randomly assigned to one of two groups Recruited patients will be randomly allocated by a computer-generated sequence of codes using randomization software httpswww randomizerorg into one of the two groups in a 11 ratio Group R to receive radial artery cannulation and Group U to receive ulnar artery cannulation using ultrasound The randomization sequence will be concealed in sequentially numbered sealed opaque envelopes The sealed envelopes will be opened by an anesthesia nurse immediately before induction of anesthesia
After induction of anesthesia modified Allens test will be done by the ultrasound operator as following
An Esmarch bandage will be used to exsanguinate the selected hand for cannulation according to the operator preference for 30 seconds then the operator will apply simultaneous pressure to the ulnar and radial arteries of the chosen limb to occlude them The bandage will then be released Next the pressure over the opposed artery selected for cannulation will be released and the time in seconds it takes for color to return to the hand will be measured
Allen test results will be interpreted as follows
If color returns to the hand within 5 seconds the result of the Allen test is negative normal and the artery can safely be cannulated
If color does not return to the palm within 5 seconds the test result is positive abnormal The test will be repeated on the other hand and if the test is positive another site will be selected for cannulation and the patient will be excluded from the study
The patients wrist will be extended over a roll to keep the angle of the wrist unchanged to 30- 45 degrees After hand washing and sterile gloving skin will be prepared using alcohol-based chlorhexidine antiseptic in both groups
Assessment of proposed artery for cannulation using ultrasonography will be performed by one of 2 pediatric anesthesiologists blinded to group allocation who have performed more than 50 ultrasound guided arterial cannulation in pediatrics
Ultrasound examination will be performed using a hockey stick high frequency 5-10 MHz ultrasound probe S-NerveTM SonoSite Inc Bothell WA USA
Image depth will be set to 2- 3 cm and gain settings adjusted to enhance views Both external force and the angle will be manipulated to optimize images
The radial artery will be identified in the transverse plane and confirmed with color flow doppler then in the longitudinal plane by rotating the probe 90 degrees clockwise while maintaining the arterial image This method will be repeated for the ulnar artery All antro-posterior AP and transverse T diameters will be made at the inner intimal edge of the vessel AP diameter will be measured on both transverse and longitudinal images Cross-sectional area CSA will be calculated then as following π AP T 4 Three measurements will be collected and the average values will be used for analysis
Arterial cannulation will be performed using the long axis view in-plane technique with a 24 or 22-gauge canulae Euromed For Medical Industries SAE Cairo Egypt according to the operator preference Cannulation will be considered complete when the arterial waveform is confirmed on the monitor If cannulation is unsuccessful within the third attempt or within 10 min the case will be considered a failure at the chosen artery After the failure an alternative site will be used for cannulation and the case will be excluded from the study The overall procedure time of arterial cannulation is defined as the time interval from the first skin puncture by the canula to confirmation of the arterial waveform on the monitor After the procedure the diameter of the cannulated artery and the occurrence of hematoma or vasospasm will be evaluated with ultrasound Data will be collected by another anesthesiologist who is blinded to the group allocation
Children will be recruited into the trial during pre-operative assessment will be randomly assigned to one of two groups Recruited patients will be randomly allocated by a computer-generated sequence of codes using randomization software httpswww randomizerorg into one of the two groups in a 11 ratio Group R to receive radial artery cannulation and Group U to receive ulnar artery cannulation using ultrasound The randomization sequence will be concealed in sequentially numbered sealed opaque envelopes The sealed envelopes will be opened by an anesthesia nurse immediately before induction of anesthesia
After induction of anesthesia modified Allens test will be done by the ultrasound operator as following
An Esmarch bandage will be used to exsanguinate the selected hand for cannulation according to the operator preference for 30 seconds then the operator will apply simultaneous pressure to the ulnar and radial arteries of the chosen limb to occlude them The bandage will then be released Next the pressure over the opposed artery selected for cannulation will be released and the time in seconds it takes for color to return to the hand will be measured
Allen test results will be interpreted as follows
If color returns to the hand within 5 seconds the result of the Allen test is negative normal and the artery can safely be cannulated
If color does not return to the palm within 5 seconds the test result is positive abnormal The test will be repeated on the other hand and if the test is positive another site will be selected for cannulation and the patient will be excluded from the study
The patients wrist will be extended over a roll to keep the angle of the wrist unchanged to 30- 45 degrees After hand washing and sterile gloving skin will be prepared using alcohol-based chlorhexidine antiseptic in both groups
Assessment of proposed artery for cannulation using ultrasonography will be performed by one of 2 pediatric anesthesiologists blinded to group allocation who have performed more than 50 ultrasound guided arterial cannulation in pediatrics
Ultrasound examination will be performed using a hockey stick high frequency 5-10 MHz ultrasound probe S-NerveTM SonoSite Inc Bothell WA USA
Image depth will be set to 2- 3 cm and gain settings adjusted to enhance views Both external force and the angle will be manipulated to optimize images
The radial artery will be identified in the transverse plane and confirmed with color flow doppler then in the longitudinal plane by rotating the probe 90 degrees clockwise while maintaining the arterial image This method will be repeated for the ulnar artery All antro-posterior AP and transverse T diameters will be made at the inner intimal edge of the vessel AP diameter will be measured on both transverse and longitudinal images Cross-sectional area CSA will be calculated then as following π AP T 4 Three measurements will be collected and the average values will be used for analysis
Arterial cannulation will be performed using the long axis view in-plane technique with a 24 or 22-gauge canulae Euromed For Medical Industries SAE Cairo Egypt according to the operator preference Cannulation will be considered complete when the arterial waveform is confirmed on the monitor If cannulation is unsuccessful within the third attempt or within 10 min the case will be considered a failure at the chosen artery After the failure an alternative site will be used for cannulation and the case will be excluded from the study The overall procedure time of arterial cannulation is defined as the time interval from the first skin puncture by the canula to confirmation of the arterial waveform on the monitor After the procedure the diameter of the cannulated artery and the occurrence of hematoma or vasospasm will be evaluated with ultrasound Data will be collected by another anesthesiologist who is blinded to the group allocation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None