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

• Conditions: Perioperative/Postoperative Complications; Exercise Tolerance; Surgery
• Interventions: Diagnostic Test: Aortic pulse wave velocity measurement; Diagnostic Test: 6 minutes walking test

• Registration Number: NCT03866915
• Lead Sponsor: Grupo Español de Rehabilitación Multimodal

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-06
• Last Update Submitted: 2019-03-06
• Study First Posted: 2019-03-07
• Last Update Posted: 2019-03-07
• Study Start: 2019-05-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing elective surgery	6 minutes walking test	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
Patients undergoing elective surgery	Aortic pulse wave velocity measurement	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

Primary Outcome Measures

Name	Time	Method
AoPWV validity: relationship between AoPWV and 6MWT distance	1 day	The validity of AoPWV-physiological parameter measured non-invasively by photoplethysmography-will be evaluated to predict the distance traveled in 6MWT in adult patients undergoing any type of elective surgery

Secondary Outcome Measures

Name	Time	Method
AoPWV threshold	1 day	AoPWV threshold associated with a 6MWD threshold of 427 meters that defines the patient at risk

Trial Locations

Locations (3)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain