Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-06-01

Brief Summary

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Methods: Prospective observational study in adult patients requiring preoperative evaluation

Objectives: To determine the correlation between the aortic pulse wave velocity (AoPWV) and the distance walked in the 6-minute walk test (6MWT) Sample Size: For a desired precision of estimate of ± 0.10 (95% confidence interval) around a postulated validity correlation coefficient of r = 0.70 (for an AoPWV in the distance prediction of 6MWT) a sample of 100 patients. By allowing a 25% wear rate, a final sample size of 125 participants is required Inclusion criteria: Patients older than 18 years undergoing any surgery and who require pre-anesthesia Statistical analysis If the variables have a normal distribution, the Pearson correlation coefficient (r2) is used, which is between -1 and 1. Where -1 indicates the highest possible negative linear relationship (increasing the value of a variable decreases the another), 0 that there is no association, +1 positive correlation. From 0.7 negative or positive, it is said that the association is strong.

Linear regression models of ordinary least squares will be applied to obtain the validity coefficient (r) and the standard error of the estimate (SEE): the typical error associated with the prediction the AoPWV with the distance traveled in the 6MWD test in each individual patient. The analysis of the receiver operating characteristic curve (ROC) will be used to derive cutoff points for an AoPWV value for the prediction of a 6MWD less than 427 meters

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Detailed Description

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Conditions

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Perioperative/Postoperative Complications Surgery Exercise Tolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients undergoing elective surgery

All patients older than 18 years undergoing elective surgery that receive a preoperative visit by anesthesiologists in which Aortic pulse wave velocity measurement and the 6 minutes walking test (6MWT) is carried out

Aortic pulse wave velocity measurement

Intervention Type DIAGNOSTIC_TEST

Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography

6 minutes walking test

Intervention Type DIAGNOSTIC_TEST

This test is performed routinely in the pre-rehabilitation units or in external anesthesiology consultations during the preoperative visit. In essence, it consists in measuring the maximum distance the patient is able to walk in 6 minutes, in a short walk in a corridor, simultaneously assessing the heart rate, oxygen saturation and the degree of dyspnea. In general, healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex.

Interventions

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Aortic pulse wave velocity measurement

Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography

Intervention Type DIAGNOSTIC_TEST

6 minutes walking test

This test is performed routinely in the pre-rehabilitation units or in external anesthesiology consultations during the preoperative visit. In essence, it consists in measuring the maximum distance the patient is able to walk in 6 minutes, in a short walk in a corridor, simultaneously assessing the heart rate, oxygen saturation and the degree of dyspnea. In general, healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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6MWT

Eligibility Criteria

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Inclusion Criteria

* All patients older than 18 years undergoing elective surgery that receive a preoperative visit by anesthesiologists.

Exclusion Criteria

* Patients undergoing emergency surgery

* Patients under 18 years of age
* Patients who refuse to participate
* Patients unable to perform the 6MWT
* Claudication of the lower extremities and inability to maintain a constant pace of walking on level ground

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes