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

16 juli 2026 bijgewerkt door: Assistance Publique - Hôpitaux de Paris

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Septische shock

Interventie / Behandeling

Diagnostische toets: Swan-Ganz IQ™, Smart Wedge

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Xavier MONNET
Telefoonnummer: 0145213539
E-mail: xavier.monnet@aphp.fr

Studie Contact Back-up

Naam: Nicolas FAGE
E-mail: nicolas.fage@aphp.fr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
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) Tijdsspanne: 1 day	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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value Tijdsspanne: 1 day	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. Tijdsspanne: 1 day	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. Tijdsspanne: 1 day	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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Onderzoekers

Studie directeur: Xavier MONNET, Assistance Publique - Hôpitaux de Paris

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juli 2026

Primaire voltooiing (Geschat)

10 juli 2028

Studie voltooiing (Geschat)

10 juli 2028

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria