NCT05249036

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

January 26, 2022

Last Update Submit

August 13, 2024

Conditions

Keywords

Arterial cannulationUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Characteristics of arterial waveform

    Within 15 mins of catheterisation.

  • Complications

    24 hours

Study Arms (2)

Ultrasound guided arterial cannulation

EXPERIMENTAL

Anaesthetist will use real-time ultrasound guidance to guide arterial cannulation

Procedure: Ultrasound guided arterial cannulation

Palpation guided arterial cannulation

ACTIVE COMPARATOR

Anaesthetist will use palpation (standard-of-care) technique to guide arterial cannulation

Procedure: Palpation guided arterial cannulation

Interventions

Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using real-time ultrasound guidance

Ultrasound 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)

Palpation guided arterial cannulation

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Requiring overnight hospital stay.

You may not qualify if:

  • Anatomical deformity
  • Unable to consent
  • Cannulation attempt within 24 hours
  • Overlying infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal London Hospital

London, E1, United Kingdom

Location

Related Publications (1)

  • Lan-Pak-Kee V, Ackland GL, Egan TC, Abbott TE, Elsheikh F; Arterial Cannulation with Ultrasound Investigators. Arterial cannulation with ultrasound: clinical trial protocol for a randomised controlled trial comparing handheld ultrasound versus palpation technique for radial artery cannulation. BJA Open. 2022 Dec;4:None. doi: 10.1016/j.bjao.2022.100111.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 21, 2022

Study Start

December 25, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations