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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02860754
Other study ID # 5392
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2016
Est. completion date December 2019

Study information

Verified date March 2019
Source McGill University Health Center
Contact Amal Bessissow, MD
Phone 514-934-1934
Email amal.bessissow@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada McGill University Health Center Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure the additive prognostic value of 6MWT to the RCRI score 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. At 30 day after surgery
Secondary Compare self reported MET score to 6MWT distance Determine whether the MET score reported by the patient is comparable to the MET score derived from the 6MWT distance covered. At preoperative clinic visit. Only one measure
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