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

16. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Septisk sjokk

Intervensjon / Behandling

Diagnostisk test: Swan-Ganz IQ™, Smart Wedge

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Xavier MONNET
Telefonnummer: 0145213539
E-post: xavier.monnet@aphp.fr

Studer Kontakt Backup

Navn: Nicolas FAGE
E-post: nicolas.fage@aphp.fr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
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) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value Tidsramme: 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. Tidsramme: 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. Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assistance Publique - Hôpitaux de Paris

Etterforskere

Studieleder: Xavier MONNET, Assistance Publique - Hôpitaux de Paris

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. juli 2026

Primær fullføring (Antatt)

10. juli 2028

Studiet fullført (Antatt)

10. juli 2028

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene