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Arterial Cannulation With Ultrasound (ArCanUS)

Primary Purpose

Perioperative/Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasound guided arterial cannulation
Palpation guided arterial cannulation
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative/Postoperative Complications focused on measuring Arterial cannulation, Ultrasound

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Royal London HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound guided arterial cannulation

Palpation guided arterial cannulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Characteristics of arterial waveform
Assessment for presence of: (1) Dicrotic notch; (2) >1 oscillation after fast flush; (3) <3 oscillations after fast flush
Complications
Recannulation required before/after surgery, infection, hematoma, thrombus.

Full Information

First Posted
January 26, 2022
Last Updated
May 16, 2023
Sponsor
Queen Mary University of London
Collaborators
The London Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05249036
Brief Title
Arterial Cannulation With Ultrasound
Acronym
ArCanUS
Official Title
Arterial Cannulation With Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
The London Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications
Keywords
Arterial cannulation, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided arterial cannulation
Arm Type
Experimental
Arm Description
Anaesthetist will use real-time ultrasound guidance to guide arterial cannulation
Arm Title
Palpation guided arterial cannulation
Arm Type
Active Comparator
Arm Description
Anaesthetist will use palpation (standard-of-care) technique to guide arterial cannulation
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided arterial cannulation
Intervention Description
Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using real-time ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
Palpation guided arterial cannulation
Intervention Description
Arterial cannulation will be attempted at the site of the radial artery of the non-dominant hand, using palpation technique (standard-of-care)
Primary Outcome Measure Information:
Title
Success rate at first attempt to cannulate the radial artery
Description
Success is defined as radial artery cannulation resulting in a transduced arterial waveform. First attempt is defined as one needle puncture through the skin.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Characteristics of arterial waveform
Description
Assessment for presence of: (1) Dicrotic notch; (2) >1 oscillation after fast flush; (3) <3 oscillations after fast flush
Time Frame
Within 15 mins of catheterisation.
Title
Complications
Description
Recannulation required before/after surgery, infection, hematoma, thrombus.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Anatomical deformity Unable to consent Cannulation attempt within 24 hours Overlying infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Lan-Pak-Kee
Phone
02035941328
Email
vlan@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Gareth Ackland
Email
g.ackland@qmul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth L Ackland, PhD FRCA
Organizational Affiliation
Translational Medicine & Therapeutics, William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Val Lan-Pak-Kee, FRCA

12. IPD Sharing Statement

Plan to Share IPD
No

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Arterial Cannulation With Ultrasound

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