Septic Shock
Conditions
Keywords
Swan-ganz IQ™, Swan-Ganz, pulmonary artery occlusion preassure
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.
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.
Interventions
DIAGNOSTIC_TESTSwan-Ganz IQ™, Smart Wedge
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify situations where there is a risk of discrepancy in the "Smart Wedge" value | 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. |
| Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert. | 1 day | Describe the variation and the relationship between the PAOP values measured by the "Smart Wedge" algorithm and those determined by expert interpretation. |
| 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 | 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. |
Contacts
CONTACTXavier MONNET
CONTACTNicolas FAGE
STUDY_DIRECTORXavier MONNET
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed