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

16 juli 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Septisk chock

Intervention / Behandling

Diagnostiskt test: Swan-Ganz IQ™, Smart Wedge

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
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) Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value Tidsram: 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. Tidsram: 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. Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Utredare

Studierektor: Xavier MONNET, Assistance Publique - Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 juli 2026

Primärt slutförande (Beräknad)

10 juli 2028

Avslutad studie (Beräknad)

10 juli 2028

Studieregistreringsdatum

Först inskickad

8 juli 2026

Först inskickad som uppfyllde QC-kriterierna