Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chair lift test.
- Who it may be relevant to
- Registry conditions: Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current pulmonary embolism risk stratification score using the sPESI score refined by the use of cardiac biomarkers and right ventricular dysfunction
Interventions
- Other chair lift test
repetitions of the sit-stand position at a self-timed speed (safe and comfortable) as many times as possible for 1 minute
Primary outcome measures
- sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the one-minute chair rise test in comparison with the gold standard refined by the use of cardiac biomarkers and right ventricular dysfunction [Time frame: 1 day]
Secondary outcome measures (3)
- Troponin measurement [Time frame: 1 day]
- Presence or absence of post-pulmonary embolism dyspnea [Time frame: 6 months]
- Overall survival [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of pulmonary embolism according to clinical algorithm, confirmed by thoracic angioscan or ventilation perfusion (V/P) scan,
- Non-serious pulmonary embolism, not requiring intensive care (thrombectomy or fibrinolysis not considered).
- sPESI score ≥ 1 \[or = 0 with elevated troponin or presence of markers of VD dysfunction, or = 0 with need for hospitalization due to comorbidities unrelated to PE (social isolation, comprehension disorders, intercurrent infection, chronic renal failure, advanced cancer...)
- Patients with no contraindications to chair lift testing (no O2 at the time of testing).
- Effective anticoagulation for at least 1 hour.
Exclusion criteria
- sPESI score = 0 with outpatient referral.
- Diagnostic confirmation of Pulmonia Embolism by thoracic angioscan or scintigraphy more than 24h after suspicion of diagnosis.
- Hospitalization > 24h after introduction of anticoagulation, with subsequent confirmation by scintigraphy.
- Any sign of serious Pulmonia Embolism, requiring hospitalization in an intensive care unit.
- Asymptomatic Pulmonia Embolism discovered by chance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Chu Rouen — Rouen
Identifiers
NCT: NCT06166329 · 2021/0386/HP