Surgery Clinical Trial
Official title:
Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery (6WAVE)
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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