Clinical trial NCT03866915: Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery
Official title: Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery (6WAVE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative/Postoperative Complications
Surgery
Exercise Tolerance
Lead sponsor: Grupo Español de Rehabilitación Multimodal
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients older than 18 years undergoing elective surgery

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


Eligibility criteria: 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

Primary outcomes:
measure: AoPWV validity: relationship between AoPWV and 6MWT distance
timeFrame: 1 day
Secondary outcomes:
measure: AoPWV threshold
timeFrame: 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Infanta Leonor University Hospital, Madrid, Spain
name: Javier Ripollés Melchor
role: STUDY_CHAIR
affiliation: Infanta Leonor University Hospital, Madrid, Spain
name: Ane Abad Motos
role: STUDY_CHAIR
affiliation: Lozano Blesa University Hospital, Zaragoza, Spain
name: José M Ramírez
role: STUDY_CHAIR
affiliation: Río Hortega University Hospital, Valladolid, Spain
name: César Aldecoa
role: STUDY_CHAIR
References: