Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05771935 |
| Other study ID # |
MS-225-2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2023 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Kasr El Aini Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The study is a double blinded randomized controlled trial that will be conducted at Abu Al
Reesh Children's 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 (https://www.
randomizer.org) into one of the two groups; in a 1:1 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 Allen's 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 patient's 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, S.A.E., 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.
