Intravenous Cannulation Clinical Trial
Official title:
Effectiveness of AccuVein AV400 Device Versus Ultrasound-guided Cannulation of the Great Saphenous Vein at the Ankle in Infants: A Randomized Controlled Trial
Establishment of venousaccess in the age group ≤12 months can be difficult and associated
with repetitive punctures . Numerous techniques to facilitate peripheral venous puncture have
been described such as local warming, epidermal nitrogycerine, translumination, and venous
cutdown . Ultrasound guidance is reported to facilitate peripheral venous catheterisation in
children and to have advantages over blind techniques, especially for challenging veins .
Also The AccuVein AV400 device which detects the haemoglobin in the vessels by red and
infrared light reflection and shows a vasculature map. AccuVein AV400 device (AV400) improves
the success rate of intravenous cannulation in pediatric patients .
Most peripheral veins in infants are too superficial and too small for direct visualization.
A promising alternative approach could be the great saphenous vein (GSV) at the level of the
medial malleolus due to the adequate diameter and the relatively deep position relative to
the skin.
The present study is designed to investigate the practicability of ultrasound-guided vascular
access versus the AccuVein AV 400 for cannulation of the great saphenous vein at the level of
the medial malleoli in infants ≤12 months. The primary outcome will be the time to successful
placement of catheters. Secondary outcomes included the number of attempts, the rate of
failure, technique-related pain, occurrence of movements, and occurrence of complications
like haematoma or local infection.
Patient and method:
A prospective, randomized study will be conducted from May 2019 till November 2019; at least
50 patients will be allocated in each group; at the Alexandria Main University Hospital after
approval of the Medical Ethics Committee. Informed written consent will be obtained from the
patient's parents. Infants' ≤12 months with ASA physical status I and II, undergoing elective
surgery with no visible veins at the dorsum of the hands or feet will be enrolled in the
study. Infants will be randomly assigned, by using a block of four randomization provided by
www.randomization.com, into two groups; an AV400 group (using the AccuVein AV400 for
peripheral venous insertion) and a ultrasound guided group (using the ultrasound for
peripheral venous insertion). The performers of cannulation will be done by expert
anesthetists, having a minimum of 5 times experience in ultra sound guided IV cannula
insertion and with the AccuVein AV400 device.
Preoperatively in all infants, both medial malleolar areas will be prepared with EMLA cream ,
premedication with 1 mg/ kg rectal midazolam (maximum dose 15 mg) will be done at 30 minutes
preoperative. Establishment of standard monitoring (SpO2, ECG, non-invasive arterial
pressure) and then induction of general anaesthesia will be done via a face mask with
sevoflurane FIO2 40% - O2/air and after successful induction of general anaesthesia, the EMLA
tapes will be removed .Assisted ventilation via the face mask will be done until
establishment of venous access either through using Acc Vein AV400 or through ultrasound
guided for the great saphenous vein. On each occasion, the observer will record the time of
tourniquet application, the time of successful cannulation or four skin punctures, and the
number of cannulation attempts. A cannulation attempt will be defined as any backward and
forward movements of the needle, regardless of whether the needle was out of the skin.
Successful cannulation will be defined by the absence of tissue swelling around the puncture
point after injection of 5 ml of crystalloid solution. In both groups, a maximal number of
three attempts for establishment of venous access in one GSV will be performed. If the third
attempt failed, the contralateral GSV will be punctured. If successful establishment of
venous access in the contralateral GSV failed, the case will be counted as failure. In these
cases, the external jugular vein will be used as an alternative approach for venous access.
After successful establishment of venous access, the anaesthetic procedure will be continued
depending on surgical requirements. Twenty-four hours after establishment of the venous
access, the puncture site will be evaluated to detect possible haematoma or local infection.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03851692 -
Intravenous Cannulation In Children During Sevoflurane Induction
|
N/A |