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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03866915
Acronym
6WAVE
Enrollment
125
Registered
2019-03-07
Start date
2019-05-01
Completion date
2019-06-01
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative/Postoperative Complications, Surgery, Exercise Tolerance

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

Interventions

DIAGNOSTIC_TESTAortic pulse wave velocity measurement

Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography

DIAGNOSTIC_TEST6 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.

Sponsors

Grupo Español de Rehabilitación Multimodal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AoPWV validity: relationship between AoPWV and 6MWT distance1 dayThe 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

MeasureTime frameDescription
AoPWV threshold1 dayAoPWV threshold associated with a 6MWD threshold of 427 meters that defines the patient at risk

Countries

Spain

Contacts

Primary ContactJavier Ripollés Melchor
ripo542@gmail.com34 620965143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026