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

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

Sponsors

Lead sponsor: Hospices Civils de Lyon

Source Hospices Civils de Lyon
Brief Summary

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.

Overall Status Recruiting
Start Date April 1, 2020
Completion Date April 1, 2021
Primary Completion Date April 1, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Capacity of the DASI self-questionnaire Day 0
Enrollment 112
Condition
Intervention

Intervention type: Other

Intervention name: DASI questionnaire

Description: All patients who accept to participate will undergo a self-questionnaire of 10 minutes. Medical data of their cardiac stress test and risk factor will be collected.

Arm group label: stable patient, referred for a VO2 peak test

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Major patients

- Patients considered stable according to the judgment of the investigator

- Indication of a stress test with measurement of VO2max as part of its medical management

Exclusion Criteria:

- Acute clinical event in the last 3 months

- System Illness Context

- Absence of coverage by a social security system

- Safeguarding justice (tutelage, guardianship, deprivation of civil rights)

- Pregnant or lactating women

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Philippe PORTRAN, PhD

Phone: 04 72 11 89 52

Phone ext: +33

Email: [email protected]

Location
facility status contact contact_backup investigator
Hopital louis Pradel Recruiting Philippe PORTRAN, PhD 04 72 11 89 52 +33 [email protected] Philippe PORTRAN, PhD Principal Investigator
Location Countries

France

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: stable patient, referred for a VO2 peak test

Description: All stable patients above 18 years, referred for a VO2 peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon) and without acute clinical event in the last 3 months. All patients who accept to participate will undergo a self-questionnaire of 10 minutes.

Acronym VAQAR
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov