Comparison of Manual PAOP and Automatic PAOP (Smart Wedge) (SMART-PAPO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Septic Shock

Treatments: Diagnostic Test: Swan-Ganz IQ™, Smart Wedge

Study type: Observational

Funder types: Other

Identifiers

NCT07703592

SMART-PAPO

Details and patient eligibility

About

The pulmonary artery catheter (Swan-Ganz) is a standard tool in intensive care for measuring and monitoring the pulmonary artery occlusion pressure (PAOP). The Swan-Ganz IQ™ model also allows automatic measurement to reduce the risk of error (Smart Wedge). However, the concordance between this automatic method and the manual method remains poorly studied in real clinical conditions and may vary depending on certain clinical situations. This study therefore aims to compare the PAOP automatically measured (Smart Wedge) with the manual PAOP measurement at bedside based on data collected in clinical practice.

Full description

The pulmonary artery catheter (or Swan-Ganz catheter) is a standard tool for measuring and monitoring PAOP in intensive care. It measures PAOP manually, which is considered the gold standard method. The Swan-Ganz IQ™ model also offers automatic measurement of PAOP during inflation of the balloon in the pulmonary artery (Smart Wedge). The ability to automatically measure PAOP would decrease the risk of error. However, the concordance between manual PAOP (reference method) and automatic PAOP (Smart Wedge) remains poorly evaluated by independent data in real clinical conditions. Furthermore, this agreement may vary depending on the clinical situation. In this context, this study aims to compare the manual PAOP measurement and the automatic PAOP measurement (Smart Wedge) based on data collected in the clinical setting.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years;
• Admission to an intensive care unit;
• Presence of a Swan-Ganz IQ™ pulmonary artery catheter placed as part of patient care;
• Measurement of pulmonary artery occlusion pressure (PAOP) performed by the attending clinician as part of patient care.

Exclusion criteria

• Pregnancy;
• Court-ordered protective measures.
• Refusal to participate by the patient's family members or the patient themselves.
• Cardiac output measurements by thermodilution or by continuous cardiac output analysis that cannot be interpreted.