Comparison of Manual PAOP and Automatic PAOP (Smart Wedge)

NCT07703592 | Not Yet Recruiting

• 1 other identifier: SMART-PAPO
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Septic Shock

Keywords

Swan-ganz IQ™; Swan-Ganz; pulmonary artery occlusion preassure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identify situations where there is a risk of discrepancy in the "Smart Wedge" value

  1 day

• Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert.

  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.

  1 day

Interventions

Swan-Ganz IQ™, Smart Wedge DIAGNOSTIC_TEST

Swan-Ganz IQ™ is a device that provides continuous measurement of cardiac index by analyzing the right ventricular pressure wave. The "Smart Wedge" module provides an automated estimate of PAPO as well as a signal quality indicator ("wedge index"), designed to assess the reliability of the measurement and alert the operator in the event of an unusable signal. This algorithm underwent regulatory validation based on retrospective data compared to an expert interpretation of selected tracings, leading to its approval for clinical use.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Xavier MONNET

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Xavier MONNET

CONTACT

0145213539; xavier.monnet@aphp.fr

Nicolas FAGE

CONTACT

nicolas.fage@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 10, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share