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

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

Study Overview

• Status: Unknown
• Conditions: Surgery; Perioperative/Postoperative Complications; Exercise Tolerance
• Intervention / Treatment: Diagnostic test: Aortic pulse wave velocity measurement; Diagnostic test: 6 minutes walking test

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Javier Ripollés Melchor; Phone Number: 34 620965143; Email: ripo542@gmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Valladolid, Spain
    • Hospital Universitario Río Hortega
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients older than 18 years undergoing elective surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: Aortic pulse wave velocity measurement; Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography; 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.; Other Names: 6MWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AoPWV validity: relationship between AoPWV and 6MWT distance	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AoPWV threshold	AoPWV threshold associated with a 6MWD threshold of 427 meters that defines the patient at risk	1 day

Collaborators and Investigators

• Sponsor: Grupo Español de Rehabilitación Multimodal
• Investigators: Study Chair: Javier Ripollés Melchor, Infanta Leonor University Hospital, Madrid, Spain; Study Chair: José M Ramírez, Lozano Blesa University Hospital, Zaragoza, Spain; Study Chair: César Aldecoa, Río Hortega University Hospital, Valladolid, Spain

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2019
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: REDGERM06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No