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

Comparison of Pulmonary Artery Occlusion Pressure (PAOP) Measurements Performed by an Expert Versus Those Obtained Using the SmartWedge Algorithm in Patients Undergoing Pulmonary Artery Catheterization (Swan-Ganz IQ™).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: Swan-Ganz IQ™, Smart Wedge

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Xavier MONNET; Phone Number: 0145213539; Email: xavier.monnet@aphp.fr
• Study Contact Backup: Name: Nicolas FAGE; Email: nicolas.fage@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the agreement between PAOP values measured by the "Smart Wedge" algorithm and PAOP values analyzed by an expert in patients in shock who are being monitored via a pulmonary artery catheter (Swan Ganz IQ)	The concordance between manual PAOP and automatic PAOP (assessed by the SmartWedge algorithm during the inflation of the ballon in the arterial pulmonary).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value	Identify situations where there is a risk of discrepancy in the "Smart Wedge" value: mechanical ventilation vs. spontaneous ventilation, high auto-PEEP, mitral regurgitation, arrhythmia.	1 day
Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert.	Describe the variation and the relationship between the PAOP values measured by the "Smart Wedge" algorithm and those determined by expert interpretation.	1 day
Assess the agreement between the PAPO value provided by the "Smart Wedge" algorithm and the PAPO value used in clinical practice, and compare it to the agreement observed between the algorithm and the expert interpretation performed retrospectively.	Evaluate the agreement between the PAPO value provided by the "Smart Wedge" algorithm and the PAPO value used in clinical practice at the patient's bedside (as recorded in the medical record by the attending clinician), and compare this agreement to that observed between the algorithm and the expert reading performed retrospectively.	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Xavier MONNET, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 10, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Swan-Ganz; Swan-ganz IQ™; pulmonary artery occlusion preassure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: SMART-PAPO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No