Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study

Not Applicable

Not yet recruiting

• Conditions: Non-severe Pulmonary Embolism
• Interventions: Other: chair lift test

• Registration Number: NCT06166329
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Study Start: 2023-12-20
• Primary Completion: 2025-06-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chair lift test	chair lift test	-

Primary Outcome Measures

Name	Time	Method
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	1 day

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months
Presence or absence of post-pulmonary embolism dyspnea	6 months
Troponin measurement	1 day