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

Not Applicable

• Conditions: Noncardiac Surgery; Postoperative Myocardial Infarction; Risk Assessment; Postoperative Death
• Interventions: Other: Six-minute walk test to perform before surgery

• Registration Number: NCT02860754
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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 Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Study Start: 2016-09-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Six-minute walk test	Six-minute walk test to perform before surgery	All patients will perform six-minute walk test before surgery, in the preoperative clinic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada