Arterial Cannulation With Ultrasound (ArCanUS)

A drop in blood pressure during anaesthesia for a surgical procedure has been associated with worse patient outcomes, including complications such as damage to the heart, brain and kidneys. Continuous blood pressure monitoring prior to the start of anaesthesia alerts the anaesthetist to drops in blood pressure and allows this to be treated promptly. This may help to avoid the complications described above.

Continuous blood pressure monitoring is carried out by inserting a small plastic tube (cannula) into an artery. In this study, the investigators propose inserting a cannula into the radial artery in the wrist before a patient is anaesthetised for surgery. The usual technique for insertion of this cannula is for the anaesthetist to identify the site of the radial artery by feeling for an arterial pulse with the fingertips (palpation). An alternative technique for identification is to use ultrasound. Ultrasound creates a two-dimensional image of the area under the skin on a screen, enabling the operator to visualise the artery being targeted. This may reduce the number of cannulation attempts required, reducing patient discomfort.

Study Overview

• Status: Terminated
• Conditions: Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: Ultrasound guided arterial cannulation; Procedure: Palpation guided arterial cannulation

Detailed Description

The investigators will test whether ultrasound guidance improves the success rate of radial artery cannulation, compared to palpation alone, in a randomised controlled trial in an NHS hospital. Patients will be over 45 years old, undergoing general or neuraxial anaesthesia for non-cardiac surgery lasting 120 minutes or more. Patients will be randomly assigned to a palpation or ultrasound-guided technique for arterial cannulation. Patients will receive numbing local anaesthetic cream to the area beforehand. A needle is used to introduce the cannula into the artery. There will be a maximum of one attempt allowed. In addition to measuring success rate, we will also compare whether the successfully sited cannula provides an adequate arterial waveform, requires resiting at any point during the surgery and any complications which arise directly related to arterial catheterisation. Patients will receive standard anaesthetic and surgical care in all other respects.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1
    • Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients scheduled to undergo major elective or urgent (not requiring intervention in <24 hours) non-cardiac surgery under general anaesthesia and/or neuraxial anaesthesia, expected to take >120 minutes from induction of anaesthesia
2. Requiring overnight hospital stay.

Exclusion Criteria:

1. Anatomical deformity
2. Unable to consent
3. Cannulation attempt within 24 hours
4. Overlying infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guided arterial cannulation; Anaesthetist will use real-time ultrasound guidance to guide arterial cannulation	Procedure: Ultrasound guided arterial cannulation; Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using real-time ultrasound guidance
Active Comparator: Palpation guided arterial cannulation; Anaesthetist will use palpation (standard-of-care) technique to guide arterial cannulation	Procedure: Palpation guided arterial cannulation; Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using palpation technique (standard-of-care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate at first attempt to cannulate the radial artery	Success is defined as radial artery cannulation resulting in a transduced arterial waveform. First attempt is defined as one needle puncture through the skin.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of arterial waveform	Assessment for presence of: (1) Dicrotic notch; (2) >1 oscillation after fast flush; (3) <3 oscillations after fast flush	Within 15 mins of catheterisation.
Complications	Recannulation required before/after surgery, infection, hematoma, thrombus.	24 hours

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Collaborators: The London Clinic
• Investigators: Principal Investigator: Gareth L Ackland, PhD FRCA, Translational Medicine & Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Arterial cannulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 301584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No