Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05956028 |
| Other study ID # |
MD-159-2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Kasr El Aini Hospital |
| Contact |
Khaled Sarhan, MD |
| Phone |
+201020067816 |
| Email |
khaled.sarhan[@]kasralainy.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV
and supraclavicular SCV cannulation in infants weighing less than 5 kg.
Description:
The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV
and supraclavicular SCV cannulation in infants weighing less than 5 kg.
It is hypothesized that ultrasound guided supraclavicular SCV cannulation has a higher
success rate compared to IJV cannulation.
Infants will be recruited into the trial during pre-operative assessment. Recruited infants
will be randomly assigned to one of two groups in a 1:1 ratio; (group S) to receive
ultrasound guided SCV cannulation and (group I) to receive ultrasound guided IJV cannulation.
Randomization will be achieved using a computer-generated sequence. Concealment will be
achieved using opaque envelopes.
All infants will be anesthetized in accordance with the local policy of pediatric anesthesia
unit in Abu El-Reesh pediatric hospital-Cairo university after ethics committee approval.
After preoperative examination and upon arrival to the operating room heart rate, noninvasive
blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor
(drȁger infinity vista XL) before inhalational induction of anesthesia using titration of
sevoflurane in oxygen air mixture 60% (starting from 3% up to 8%) until the infant is put to
sleep. After securing an intravenous line anesthesia will be completed with 1-2µg/kg of
fentanyl and atracurium 0.5 mg/kg.
Induction of anesthesia will be performed by the attending senior anesthesia resident who has
finished at least 2 years of residency (who is independent of the study team).
All cannulations will be performed by 2 pediatric anesthesiologists trained in US-guided
central line placement each one has performed (more than 50 cannulations) before the study.
Catheterization will be performed using a standard Seldinger technique under sterile
conditions using high frequency (5-10 MHz) footprint ultrasound probe (S-NerveTM; SonoSite
Inc., Bothell, WA, USA).
Before the procedure, IJV or SCV veins size, patency, and collapsibility with transducer
pressure will be assessed using US probe. The cannulation side (right or left) choice and the
central venous catheter size will be decided by the practitioner preference according to the
patient's vein examination.
Group I:
The standard transverse out-of-plane approach will be used. Infants will be placed in the 10°
Trendelenburg and a shoulder roll will be placed to extend the neck, which will be rotated
about 30° to the opposite side of cannulation. The transducer will be placed in a transverse
position over the patient's neck at the level of cricoid cartilage to identify IJV and common
carotid artery (CCA) in short-axis view. The CCA and the IJV will be differentiated by
pulsations of the artery and compressibility of the vein. The vein will be then centered on
the screen. The skin puncture will be made in the center of the US image using a needle
without syringe. The needle will be introduced at an angle of 60° to the skin surface,
perpendicular to the transducer. The needle will be advanced toward IJV until an indentation
of the anterior wall of the vein is noticed. If spontaneous blood flashback is obtained, the
guide wire will be introduced into the vein and the procedure will be completed using
Seldinger's technique. If no spontaneous blood return is observed despite clear visualization
of the needle bevel in the vessel lumen on US, a syringe will be attached to the needle hub
to aspirate blood and then the guide wire will be introduced into the vein and the procedure
will be completed. The attempt will be considered successful when smooth insertion of the
guidewire into the vein after confirmation of the site of the wire in the right atrium using
intraoperative x ray. If blood could not be aspirated, the needle will be withdrawn, the
attempt will be considered failed and another attempt will be made to a maximum of 3
attempts. If failure more than 3 attempts, another site will be chosen and the patient will
be excluded from the study.
Group S:
The patient will be positioned with the neck extended and rotated 45° opposite to the
cannulation side. A towel roll will be placed under the shoulders for adequate neck
extension. The US probe will be placed against and above the clavicle to visualize the
transversal view of carotid artery and IJV, and then will be slowly tilted against the
infant's cheek, showing first the subclavian artery in longitudinal view, and then, more
anterior, the SCV, lying on the pleural line.
After obtaining a satisfactory image of the SCV in the longitudinal axis, the needle will be
introduced without syringe in an in-plane technique. If spontaneous blood flashback is
obtained, the guide wire will be introduced into the vein and the procedure will be completed
using Seldinger's technique. If no spontaneous blood return is observed despite clear
visualization of the needle bevel in the vessel lumen on US, a syringe will be attached to
the needle hub to aspirate blood and then the guide wire will be introduced into the vein and
the procedure will be completed. The attempt will be considered successful when smooth
insertion of the guidewire into the vein after confirmation of the site of the wire in the
right atrium using intraoperative x ray. If blood could not be aspirated, the needle will be
withdrawn, the attempt will be considered failed and another attempt will be made. If failure
more than 3 attempts, another site will be chosen, and the patient will be excluded from the
study.
