NCT04163731: VAQAR

VAlidation of an Self Administered Questionnaire in French for Assessment of Cardio Respiratory Reserve

Completed Last updated 4 March 2022

What this trial tests

trial testing DASI questionnaire in Cardiovascular Diseases in 145 participants. Completed in 11 March 2021.

Timeline

18 May 2020

Primary endpoint
11 March 2021

11 March 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	145
Start date	18 May 2020
Primary completion	11 March 2021
Estimated completion	11 March 2021
Sites	1 location across France

Drugs / interventions tested

• DASI questionnaire

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation.

Indeed, below a certain threshold of VO2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 Metabolic Equivalent of Task - MET), the ESC recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients.

In current practice, this evaluation is performed in anesthesia consultation by non-standard interview. The question "Can you go up a floor or climb a hill?" permits to classify patients with more or less VO2 peak than 4 MET.

However, several studies, including one published in the Lancet in 2018, show that this evaluation doesn't assess correctly the VO2peak of the patients nor predict post-operative cardiac complications.

In the same study, the evaluation of a standardized self-questionnaire, the Duke Activity Status Index (DASI), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction.

This self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). It has also been validated in medical patients as being well correlated with the value of VO2 peak in the case of an answer by a third party (r = 0.81, p \<0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p \<0.001).

This self-questionnaire exists in English but there is no validated translation in French. Given the cultural differences, it seems necessary in order to use it in a French-speaking context to go through a scientific validation stage. A validation study of DASI in Portuguese has already been published recently, serving as a methodological basis for a French translation.

The purpose of this study is to carry out a validation of a standardized self-questionnaire in French. It will be distributed to patients referred for a VO2peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon). The results of VO2peak predicted by the self-questionnaire will be compared to the VO2 peak measured during the examination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.