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

NCT03866915 | Unknown

• 1 other identifier: REDGERM06
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 3

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

Conditions

Perioperative/Postoperative Complications; Surgery; Exercise Tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AoPWV threshold

  1 day

Study Arms (1)

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; Diagnostic Test: 6 minutes walking test

Interventions

Aortic pulse wave velocity measurement DIAGNOSTIC_TEST

Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography

Patients undergoing elective surgery

6 minutes walking test 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.

Also known as: 6MWT

Patients undergoing elective surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients older than 18 years undergoing elective surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal: lead

Study Sites (3)

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Ripollés Melchor

  Infanta Leonor University Hospital, Madrid, Spain

  STUDY CHAIR

• Ane Abad Motos

  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 CHAIR

Central Study Contacts

Javier Ripollés Melchor

CONTACT

34 620965143; ripo542@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

ES (3)