Condition category
Surgery
Date applied
10/10/2008
Date assigned
28/11/2008
Last edited
28/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerard Danjoux

ORCID ID

Contact details

Department of Anaesthesia
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1 July 2008

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to examine the validity of the six minute walk test (6MWT) (maximum distance walked; undertaken at pre-operative assessment for scheduled major non-cardiac surgery) against two criterion measures derived from cardiopulmonary exercise testing (CPET) - anaerobic threshold (AT) and peak oxygen consumption (VO2 peak).

Ethics approval

South Humber Research Ethics Committee gave approval on the 27th August 2008 (ref: 08/H1305/62).

Study design

Prosepective observational concurrent validity study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-operative assessment

Intervention

This is a concurrent validity study. In practice all participants will complete two exercise tests during their attendance at the pre-operative assessment clinic. After gaining consent the participants will first perform a cardiopulmonary exercise test using a cycle ergometer. Then after a rest period they will complete a supervised six minute walk test. The results of the two tests will be read after completion. Patient characteristics and risk assessment data will be collected from the notes during the clinic. The participant will have no further involvement after this clinic attendance. We will collect post-hoc surgical outcome data after discharge from hospital.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The outcome of a concurrent validity study is determined by the two criterion measures (AT and VO2 peak) and the two predictors (walking distance and body weight product). This will allow us to calculate the typical predictive error in the estimation of AT from the results of a 6MWT. This is measured during clinic attendance.

Secondary outcome measures

Recorded after discharge from hospital:
1. Morbidity and mortality, 30-day mortality also collected 30 days from discharge
2. Length of stay in critical care, measured in days
3. Length of stay in hospital, measured in days
4. Further measures of pre-operative assessment will be analysed in order to best assess the estimation of exercise capacity

Overall trial start date

01/10/2008

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 50 and 85 years of age, either sex
2. Awaiting major surgery for: colorectal resection, upper gastrointestinal tract disease, major vascular procedures, major urological and major gynaecological procedures
3. Identified through the surgical pre-operative assessment clinics where participants are routinely assessed prior to surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Emergency surgery
2. Aged less than 50 and greater than 85 years
3. Medical conditions causing inability to walk
4. Unable to complete baseline CPET test
5. Unable to give informed consent
6. Medical contraindications to CPET and 6MWT:
6.1. New York Heart Association Functional Classification greater than or equal to Class III
6.2. Canadian Cardiovascular Society Angina Grading Scale greater than or equal to Class III
6.3. European Society of Hypertension Classification Grades greater than or equal to III
7. Aortic stenosis greater than or equal to moderate (i.e. valve area less than 1.0 cm^2)
8. Hypertrophic cardiomyopathy
9. Symptomatic arrhythmias
10. Spinal cord injury
11. Primary muscular disorder
12. Uncontrolled epileptic seizures
13. Pregnancy

Recruitment start date

01/10/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

James Cook University Hospital (UK)

Sponsor details

Marton Road
Cleveland
Middlesbrough
TS4 3BW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.southtees.nhs.uk/live/

Funders

Funder type

Hospital/treatment centre

Funder name

James Cook University Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21980122

Publication citations

  1. Results

    Sinclair RC, Batterham AM, Davies S, Cawthorn L, Danjoux GR, Validity of the 6 min walk test in prediction of the anaerobic threshold before major non-cardiac surgery., Br J Anaesth, 2012, 108, 1, 30-35, doi: 10.1093/bja/aer322.

Additional files

Editorial Notes