An observational study in Cardiovascular Diseases, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by Hospices Civils de Lyon · Observational
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 145 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Other: DASI questionnaire
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.
Capacity of the DASI self-questionnaire
Sensitivity and specificity of the DASI self-questionnaire translated into French to identify patients with a threshold of VO2max \<14 milliliters (mL) O2 kilogram-1 minute-1 measured during the exercise test.
Time frame: Day 0
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon