Condition category
Surgery
Date applied
01/12/2016
Date assigned
05/12/2016
Last edited
05/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cannulation is a commonly used medical procedure where a small tube is inserted into a vein or artery for access. Radial artery (the main artery in the forwarm) cannulation is used routinely in clinical settings for many purposes, such as accurate monitoring of beat-to-beat blood pressure, repeated multiple blood sampling and some surgical procedures. The radial artery is small, and so can be very difficult to cannulate however. Multiple attempts to cannulate can be risky and lead to risk and complications such as temporarily blocking the artery (occlusion), blood clots and bleeding. It is therefore important to find an easy, convenient and quick method for accessing the radial artery. In recent years, ultrasound (US) devices have been used to visualise blood vessels in order to access them with a cannula. Additionally use of a tourniquet (tight band to cut of blood supply) can also help improve cannulation success rates. The aim of this study is to find our whether using a tourniquet can improve the success rate of radial artery cannulation when using ultrasound.

Who can participate?
Adults undergoing major non-emergency surgery who require continuous beat-to-beat blood pressure monitoring throughout their operation.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have a tourniquet tied as tightly as possible around the arm. Those in the second group have a tourniquet loosely tied on the far-end of the wrist. Following this, participants in both groups are cannulated using an ultrasound probe to visualise the artery. The time taken to successfully place the cannula is recorded for participants in both groups.

What are the possible benefits and risks of participating?
Participants could benefit from improved success rates of cannulation and a shorter cannulation time. There are no notable risks of participating other than the general risks associated with cannulation, such as pain or bruising.

Where is the study run from?
Shanghai Jiaotong University Affiliated Shanghai No.6 People’s Hospital (China)

When is the study starting and how long is it expected to run for?
March 2014 to December 2016

Who is funding the study?
Investigator initiated and funded (China)

Who is the main contact?
Ms Quanhong Zhou

Trial website

Contact information

Type

Scientific

Primary contact

Miss Quanhong Zhou

ORCID ID

Contact details

600 Yishan Road
Shanghai
200233
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2014-19

Study information

Scientific title

When tourniquet meets ultrasound for radial artery cannulation: A way to improve the quality of monitoring

Acronym

Study hypothesis

Distal tightened tourniquet may facilitate ultrasound guided radial artery cannulation.

Ethics approval

Institutional Review Board of Shanghai Jiaotong University-affiliated Shanghai No.6 People’s Hospital, 26/03/2014, ref: 2014-19

Study design

Randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Radial artery cannulation

Intervention

Participants are randomly allocated to one of two groups using the sealed envelope technique. In both groups, the tourniquet is placed distally to the ulnar styloid process.

Group 1: The tourniquet is tied as tightly as possible

Group 2: The tourniquet is loosely tied on the far-end of the wrist

Following application of the tourniquet, an assistant sterilizes the forearm skin and put a sheet with hole at the insertion site to cover the tourniquet. Doctor could not see the tourniquet when performing the cannulation. An ultrasound probe is used to search for the optimal site for needle insertion and the needle is inserted at the center of the probe. If blood flushes out, the sheath of the needle is inserted and the needle taken out. The sheath is then connected to monitor (CARESCAPE, GE) via a pressure sensor (Combitrans Arterial Monitoring Kit B/BRAUN). A successful cannulation is announced when an arterial wave is shown on the monitor. The time from needle insertion to the successful wave shown is defined as radial artery cannulation time.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

First-attempt success rate is measured by how many patients had first-attempt success out of the whole population in his/her group (n=120) at the end of the study.

Secondary outcome measures

1. Number of attempts is counted and verified using ultrasound scanning
2. Failure rate is measured by how many patients had failed out of the whole population in his/her group (n=120) at the end of the study
3. Time used for cannulation is measured using stopwatch by assistant at the process of cannulation
4. Frequency of posterior wall technique used is measured by how many patients had posterior wall technique out of the whole population in his/her group (n=120) at the end of the study

Overall trial start date

01/03/2014

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Undergoing elective major surgery
3. Assumed to require continuous blood pressure monitor during their operation

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Patients with abnormal Allen test
2. Peripheral vascular diseases
3. Scars at the forearm i.e. insertion site

Recruitment start date

07/04/2014

Recruitment end date

01/12/2015

Locations

Countries of recruitment

China, Christmas Island

Trial participating centre

Shanghai Jiaotong University Affiliated Shanghai No.6 People’s Hospital
600 Yishan Road
Shanghai
200233
China

Sponsor information

Organisation

Shanghai Jiaotong University affiliated Shanghai Sixth People’s hospital

Sponsor details

600 Yishan Road
Shanghai
200233
China

Sponsor type

Hospital/treatment centre

Website

www.6thhosp.com

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a low-medium-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Quanhong Zhou, zhouanny@hotmail.com

Intention to publish date

01/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes