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

Grupo Español de Rehabilitación Multimodal

Status: Unknown

Conditions: Surgery; Perioperative/Postoperative Complications; Exercise Tolerance

Treatments: Diagnostic Test: Aortic pulse wave velocity measurement; Diagnostic Test: 6 minutes walking test

Study type: Observational

Funder types: Other

Identifiers

NCT03866915

REDGERM06

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

125 participants in 1 patient group

Patients undergoing elective surgery

Description:

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

Treatment:

Diagnostic Test: 6 minutes walking test

Diagnostic Test: Aortic pulse wave velocity measurement