The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT02860754
Collaborator
(none)
1,000
1
1
38.8
25.8

Study Details

Study Description

Brief Summary

This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac surgery. In addition, this study will assess whether the patients' reported MET score corresponds to the determined MET score from the 6MWT distance completed.

Condition or Disease Intervention/Treatment Phase
  • Other: Six-minute walk test to perform before surgery
N/A

Detailed Description

Study investigators propose to undertake a prospective cohort study at the preoperative clinics of the Royal-Victoria and Montreal General Hospitals of McGill University Health Centre. All patients with planned noncardiac surgery under general or regional anesthesia will be considered for inclusion.

Eligible consenting patients will undergo the 6MWT during their preoperative clinical visit, typically occurring within a few weeks before surgery. This test will be performed by a trained health care worker. Patients will walk back and forth along a 20 m corridor, while attempting to cover as much ground as possible in 6 minutes. Patients will be allowed to rest on the chairs while performing the test if necessary. Patients will be encouraged to resume walking as soon as patients feel physically able. The total covered distance in 6 minutes will be measured to the nearest meter.

The RCRI score will be calculated for each study participant.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery: Prospective Cohort Study
Actual Study Start Date :
Sep 7, 2016
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Six-minute walk test

All patients will perform six-minute walk test before surgery, in the preoperative clinic

Other: Six-minute walk test to perform before surgery
During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.

Outcome Measures

Primary Outcome Measures

  1. Measure the additive prognostic value of 6MWT to the RCRI score [At 30 day after surgery]

    Investigate the additive prognostic value of the 6MWT to the RCRI score for predicting major cardiovascular complications at 30 day after surgery, in patients undergoing noncardiac surgery.

Secondary Outcome Measures

  1. Compare self reported MET score to 6MWT distance [At preoperative clinic visit. Only one measure]

    Determine whether the MET score reported by the patient is comparable to the MET score derived from the 6MWT distance covered.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
All patients fulfilling all the following inclusion criteria will be enrolled:
  • Patients aged ≥ 50 year old and undergoing elective noncardiac surgery, under general anesthesia or regional anesthesia.

  • Patients with planned surgery within 3 months of the preoperative visit.

Patients with at least one of the following medical conditions:
  • Hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, transient ischemic attack, stroke, or peripheral vascular disease.
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
  • Patients with a condition preventing mobilization for 6 minutes.

  • Patients with significant cardiac disease (e.g., low-threshold angina (angina that occurs with minimal exertion), severe aortic stenosis).

  • Patients with severe pulmonary disease restricting mobility.

  • Patients refusing to participate.

  • Patients previously enrolled in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 McGill University Health Center Montreal Quebec Canada H4A 3J1

Sponsors and Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Amal Bessissow, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amal Bessissow, MD, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT02860754
Other Study ID Numbers:
  • 5392
First Posted:
Aug 9, 2016
Last Update Posted:
Mar 14, 2019
Last Verified:
Mar 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2019