Ultrasound Guided Ulnar Versus Radial Artery in Pediatrics Undergoing Major Non Cardiac Surgery

NCT05771935 | Completed

• 1 other identifier: MS-225-2022
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pediatrics; Radial Artery; Ulnar Artery

Keywords

ultrasound; arterial cannulation; radial; ulnar; surgery

Outcome Measures

Primary Outcomes (1)

• Rate of successful cannulation at first attempt

  (the procedure will be classified as successful when the artery is cannulated, and an arterial waveform is recorded within less than 3 attempts and or 15 minutes from the first puncture).

  15 minutes

Secondary Outcomes (3)

• diameters of the arteries before cannulation

  preoperative

• diameters of the arteries after cannulation

  15 minutes from start of cannulation

• incidence of vasospasm

  15 minutes from start of cannulation

Study Arms (2)

(Group R)

EXPERIMENTAL

receive radial artery cannulation using ultrasound

Procedure: ultrasound guided radial versus ulnar artery cannulation

(Group U)

ACTIVE COMPARATOR

receive ulnar artery cannulation using ultrasound

Procedure: ultrasound guided radial versus ulnar artery cannulation

Interventions

ultrasound guided radial versus ulnar artery cannulation PROCEDURE

Ultrasound examination will be performed using a hockey stick, high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA). . Arterial cannulation will be performed using the long axis view (in-plane) technique with a 24 or 22-gauge canulae 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.

(Group R); (Group U)

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- All pediatrics ASA I\&II aged 1 month -10 years undergoing major non cardiac surgeries.

You may not qualify if:

• Patients undergoing cardiac surgeries.
• Refusal of parents.
• Ischemia defined as (color changes: blanching, duskiness, and or change in temperature of the extremity used for cannulation compared to the contralateral one).
• Previous arterial cannulation within last week.
• Patients requiring inotropic support before the start of procedures.
• Rash or signs of infection or hematoma at the site of cannulation.
• Patients requiring emergency procedures.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator,Lecturer of anesthesia, Cairo university

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: March 5, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

EG (1)