Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04617106 |
| Other study ID # |
686-2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2020 |
| Est. completion date |
March 27, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Tribhuvan University Teaching Hospital, Institute Of Medicine. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Radial Artery cannulation using conventional palpation vs USG guided Dynamic needle tip
positioning (DNTP) method.
Description:
Management protocol of patients
A day before surgery All the patients included in the study will be explained in detail about
the purpose of the study, and the need, benefits, and risks of arterial cannulation and the
purpose of the study.
Written informed consent will be obtained during the pre-anaesthetic checkup. Patients will
be asked to remain nil per oral as per standard American Society of Anesthesiologists
guidelines. Premedication will be advised as per institutional protocol.
Pre-anaesthetic room After shifting from the ward to the pre-anaesthetic room, an intravenous
line will be secured with an 18 or 20 G cannula in the dominant hand and baseline heart rate,
blood pressure and oxygen saturation will be recorded. The patient will then be shifted to
the operation theatre.
Operation theatre After shifting to the operating table, a pulse oximeter, a non-invasive
blood pressure monitor, and an electrocardiogram monitor will be attached.
Arterial pressure transducer and tubings will be flushed with normal saline and will be kept
ready.
Barbeaue test will be done using pulse oximetry in the thumb of the non-dominant hand to
assess the type of Ulnopalmar arch.
The anaesthesia faculty/resident/assistant not involved in the study will then be asked to
open an opaque, sealed envelope to decide the technique to be used for cannulation.
Radial artery cannulation Radial artery catheterisation will be done by the investigating
anaesthesiology resident under the supervision of the consultant anaesthesiologist in the
operation theatres.
The anaesthesia resident performing arterial cannulation must have placed at least 20 radial
arterial catheters by palpation method and 20 using USG-guided DNTP method.
The patient's arm will be slightly abducted (less than 90 degrees) from the body and placed
on an arm board and the wrist will be placed in an extended position by placing a towel roll
making an approximately 60-degrees angle with the forearm. The wrist will be then stabilised
in this position by taping it to the arm board.
To maintain asepsis, the wrist will be then prepped with povidone Iodine 10%. Surgical
gloves, sterile drapes, and a sterile plastic sheath for USG-guided technique will be used.
The investigating resident will sit on a chair of a comfortable height facing the patient's
wrist.
To anaesthetise the cannulation site, 1 ml of 2% lidocaine will be injected with a 25-gauge
needle, approximately 3 cm proximal to the distal wrist crease after wiping off the povidone
iodine with a sterile gauge.
A 20-Gauge intravenous catheter of the same trademark will be used to catheterise the radial
artery in all patients.
The timer (SEIKOSHA stopwatch, Seikosha co. ltd, Japan) will be started once the USG-probe is
placed on the prepped wrist or when the operator begins palpation of the radial pulse in the
USG-guided and palpation techniques, respectively.
Immediately after successful cannulation, an assistant will attach the pressure monitoring
tubing.
The timer will be immediately stopped once the arterial waveform appears on the monitor.
If after 300 seconds, the radial artery is not cannulated, the procedure will be aborted, and
documented as "failure to cannulate." A senior anaesthesiologist will then perform arterial
cannulation using any method at his/her discretion.
Following data will be collected Systolic and diastolic blood pressure before cannulation
using NIBP First pass success of radial cannula placement Number of cannulae used Number of
skin punctures Number of redirections Time for successful cannulation (in secs)
USG guided DNTP technique USG machine (Sonosite M-Turbo, Fujifilm Sonosite Inc. USA) with a
linear probe (6-13 MHz) will be used, using the vascular mode, optimal gain, and autofocus.
A short-axis out-of-plane view of the radial artery will be obtained and kept at 1.5 cm depth
aligned with the central line of the USG probe.
The needle and catheter will be advanced through the skin at an angle of 45 to 60 degrees
until the hyperechoic needle tip is seen on the ultrasound image.
The ultrasound probe will then be moved proximally along the forearm and away from the needle
insertion point until the needle tip disappears from the ultrasound image.
The needle and catheter will then be advanced a few millimeters until the needle tip is seen
again on the ultrasound image.
This stepwise process will be repeated several times until the needle tip is visualised in
the lumen of the radial artery.
At this point, the angle of approach will be decreased and the same process shall be
continued, keeping the needle tip in the center of the arterial lumen.
The needle and catheter assembly will be advanced stepwise for approximately 3 to 5mm inside
the arterial lumen.
If the needle is advanced through the posterior vessel wall, the operator will be allowed to
withdraw the needle slightly and advance again.
After around 3 to 5mm of the needle is advanced, the catheter will then be threaded off the
needle and the pressure-monitoring tubing will be immediately attached.
Palpation method The investigating resident will palpate the radial arterial pulse with the
non-dominant hand.
The needle and catheter assembly will be advanced towards the radial artery at a 15° to 30°
angle until a flashback of blood is observed in the needle hub.
Once flash-back of blood appears in the hub, the needle angle will be decreased slightly and
the catheter will be advanced about 3 to 5mm.
If the operator suspects puncture of the posterior arterial wall, the cannula will then be
gradually withdrawn such that the cannula tip will be in the arterial lumen. The intraluminal
position of the catheter will be ensured by blood in the catheter lumen as the needle is
being withdrawn. The needle angle will then be decreased slightly and the catheter will be
advanced.
If blood continues to flow into the hub, the catheter will be threaded off the needle and
then the pressure-monitoring tubing will be attached.
A new cannula will be used if the cannula hub is full of blood but the artery is not
cannulated successfully or there is obvious catheter kinking or shearing during redirections
or skin punctures.
After radial artery cannulation Once radial artery cannulation is complete, the cannula will
be secured with adhesive tape and injection port will be covered with an opaque dressing to
prevent inadvertent intra-arterial injection of drugs.
The wrist will then be placed in a neutral position with the forearm placed either parallel
to the torso or abducted and secured on an arm board.
Routine preoxygenation, anaesthesia induction, patient positioning, and maintenance of
anaesthesia will be done as per standard institutional practice.
