Thoracic Surgery or Aortic Vascular Surgery PatientsACUMENNCT07133126
Prediction of Arterial Hypotension by HPI: a Feasibility Study in Lung Resection Surgery and During Fenestrated Aortic Stenting Under General Anesthesia
An observational study of Thoracic Surgery or Aortic Vascular Surgery Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Background: Brief review (literature data, pathology, field of study) Thoracic lung resection surgery has specific imperatives (opening of the thorax, unipulmonary ventilation, lateral decubitus operating position) that challenge the accuracy and precision of hemodynamic monitoring tools in general [1] and of systems… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery or Aortic Vascular Surgery Patients
- What is being tested?
- Acumen monitoring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 1 Dec 2025
- 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
- Adult, Older adult
Study population: Adult subjects scheduled for lung resection by thoracotomy or video-assisted surgery or robotic surgery and patients proposed for fenestrated aortic stenting under general anesthesia
Who may be able to join
- Adult patients at moderate or high risk (ASA score ≥ 2 and/or Lee score ≥ 2)
- scheduled for lung resection by thoracotomy or video-assisted surgery or robotic surgery or fenestrated aortic stenting
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Background: Brief review (literature data, pathology, field of study) Thoracic lung resection surgery has specific imperatives (opening of the thorax, unipulmonary ventilation, lateral decubitus operating position) that challenge the accuracy and precision of hemodynamic monitoring tools in general [1] and of systems based on arterial pressure wave analysis in particular.
The ACUMEN ClearSight® medical device enhanced by the HPI algorithm, CE marked in 2023, was developed and marketed by Edwards LifeSciences. It has been the subject of some twenty medical scientific publications since 2018 [2,3]. It is a non-invasive, single-patient sensor-type device that predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy.
Read more
The prediction of intraoperative arterial hypotension by the HPI machine learning algorithm is based on the invasive or non-invasive analysis of the physiological properties of the arterial pressure wave. The device is designed to optimize blood pressure management during lung resection surgery for cancer or fenestrated thoracic aortic stenting under general anesthesia. It should also enable personalized hemodynamic optimization of vascular filling and intraoperative management of vasopressor agents in patients at cardiac risk, leading ultimately to a reduction in hospital morbidity and mortality.
Non-invasive monitoring with the ClearSight® system is used routinely in the operating room at Hôpital Louis Pradel, but without the intelligent HPI system.
- Being tested
- Acumen monitoring
- Keywords
- Non-invasive monitoring, thoracic surgery, aortic vascular surgery, HPI system, prediction, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen monitoringDevice
Patient undergoing a thoracic surgery or an aortic surgery will be monitored as usual using the CE marked medical device ACUMEN with the intelligent HPI system.
| Study group | Role | What they receive |
|---|---|---|
| Monitored patients | Patient undergoing a thoracic surgery or an aortic surgery will be need to be monitored during and after surgery monitored. We need to predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy Receives: Device: Acumen monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of ACUMEN monitoring
Number of episodes of intraoperative arterial hypotension.
Measured: During the whole surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery or Aortic Vascular Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133126
- Sponsor's protocol ID
- 24-5523
- Acronym
- ACUMEN
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Arterial Hypotension by HPI: a Feasibility Study in Lung Resection Surgery and During Fenestrated Aortic Stenting Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07133126
- Acronym / sponsor ID
- ACUMEN / 24-5523
- Keywords
- Non-invasive monitoring, thoracic surgery, aortic vascular surgery, HPI system, prediction, hypotension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Aug 2025 (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.
Background: Brief review (literature data, pathology, field of study) Thoracic lung resection surgery has specific imperatives (opening of the thorax, unipulmonary ventilation, lateral decubitus operating position) that challenge the accuracy and precision of hemodynamic monitoring tools in general [1] and of systems based on arterial pressure wave analysis in particular.
The ACUMEN ClearSight® medical device enhanced by the HPI algorithm, CE marked in 2023, was developed and marketed by Edwards LifeSciences. It has been the subject of some twenty medical scientific publications since 2018 [2,3]. It is a non-invasive, single-patient sensor-type device that predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy.
The prediction of intraoperative arterial hypotension by the HPI machine learning algorithm is based on the invasive or non-invasive analysis of the physiological properties of the arterial pressure wave. The device is designed to optimize blood pressure management during lung resection surgery for cancer or fenestrated thoracic aortic stenting under general anesthesia. It should also enable personalized hemodynamic optimization of vascular filling and intraoperative management of vasopressor agents in patients at cardiac risk, leading ultimately to a reduction in hospital morbidity and mortality.
Non-invasive monitoring with the ClearSight® system is used routinely in the operating room at Hôpital Louis Pradel, but without the intelligent HPI system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitored patients | – | Device: Acumen monitoringPatient undergoing a thoracic surgery or an aortic surgery will be need to be monitored during and after surgery monitored. We need to predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subjects scheduled for lung resection by thoracotomy or video-assisted surgery or robotic surgery and patients proposed for fenestrated aortic stenting under general anesthesia
Key inclusion criteria (2 listed)
- Adult patients at moderate or high risk (ASA score ≥ 2 and/or Lee score ≥ 2)
- scheduled for lung resection by thoracotomy or video-assisted surgery or robotic surgery or fenestrated aortic stenting
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Acumen monitoringPatient undergoing a thoracic surgery or an aortic surgery will be monitored as usual using the CE marked medical device ACUMEN with the intelligent HPI system. | Device | Monitored patients |
Primary outcome
Impact of ACUMEN monitoring
Time frame: During the whole surgery
Number of episodes of intraoperative arterial hypotension.
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 20 Aug 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery or Aortic Vascular Surgery Patients, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of ACUMEN monitoring (time frame: During the whole surgery). 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 20 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.