Septic ShockSMART-PAPONCT07703592
Comparison of Manual PAOP and Automatic PAOP (Smart Wedge)
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Swan-Ganz IQ™, Smart Wedge
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 10 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nicolas FAGE contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Swan-Ganz IQ™, Smart Wedge
- Keywords
- Swan-ganz IQ™, Swan-Ganz, pulmonary artery occlusion preassure
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-Ganz IQ™, Smart WedgeDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (3)
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value
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.
Measured: 1 day
Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert.
Describe the variation and the relationship between the PAOP values measured by the "Smart Wedge" algorithm and those determined by expert interpretation.
Measured: 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.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MONNET, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703592
- Sponsor's protocol ID
- SMART-PAPO
- Acronym
- SMART-PAPO
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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™).
- ClinicalTrials.gov ID
- NCT07703592
- Acronym / sponsor ID
- SMART-PAPO / SMART-PAPO
- Conditions
- Septic Shock
- Keywords
- Swan-ganz IQ™, Swan-Ganz, pulmonary artery occlusion preassure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in medical ICU (of Bicêtre and Angers) with pulmonary arterial catheter (PAC) place as part of routine clinical care.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swan-Ganz IQ™, Smart WedgeSwan-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. | Diagnostic test | – |
Primary outcome
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)
Time frame: 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).
3 secondary outcomes
Identify situations where there is a risk of discrepancy in the "Smart Wedge" value
Time frame: 1 day
Assess the variability between PAOP values measured by the Smart Wedge algorithm and those measured by an expert.
Time frame: 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.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas FAGE contact
Xavier MONNET study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier MONNET (0145213539, xavier.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.