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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02860754
Enrollment
1000
Registered
2016-08-09
Start date
2016-09-07
Completion date
2019-12-31
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noncardiac Surgery, Postoperative Death, Postoperative Myocardial Infarction, Risk Assessment

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.

Interventions

OTHERSix-minute walk test to perform before surgery

During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Measure the additive prognostic value of 6MWT to the RCRI scoreAt 30 day after surgeryInvestigate 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

MeasureTime frameDescription
Compare self reported MET score to 6MWT distanceAt preoperative clinic visit. Only one measureDetermine whether the MET score reported by the patient is comparable to the MET score derived from the 6MWT distance covered.

Countries

Canada

Contacts

Primary ContactAmal Bessissow, MD
amal.bessissow@mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026