Hypotension During SurgeryNCT06120296
Hypotension Prediction Index for Shoulder Surgery in Beach Chair.
A study testing Acumen Hypotension prediction Index software in people with Hypotension During Surgery, run by Geertrui Dewinter at 1 site in Belgium.
Trial summary
The beach chair position is the most commonly used position during shoulder surgery and offers the surgeon numerous advantages over the lateral decubitus position. However, the beach chair position can also lead to hemodynamic changes, including hypotension and cerebral hypoperfusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Acumen Hypotension prediction Index software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI < 40 kg/m2
- Patient can give informed consent
- ASA I-IV
- Invasive blood monitoring
- General anesthesia combined with interscalene block
Who cannot join
- - Refusal of participation
- Hypotension before surgery (MAP< 65 mmHg)
- History of stroke
- Dementia
- Contra-indication for interscalene block
- Contra-indication for general anesthesia
- Dialysis
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Anesthesie Research
Leuven, 3000
Dewinter, PhD, +3216344270, geertrui.dewinter@uzleuven.be
About this study
Official title: Effect of the Hypotension Prediction Index on the Prevalence of Intra-operative Hypotension During Shoulder Surgery in Beach Chair: A Prospective Randomized Clinical Trial.
The beach chair position is the most commonly used position during shoulder surgery and offers the surgeon numerous advantages over the lateral decubitus position. However, the beach chair position can also lead to hemodynamic changes, including hypotension and cerebral hypoperfusion. It is therefore the anesthesiologist's job to prevent hypotension during the procedure.
The Acumen Hypotension Predictor Index or HPI for short is a software program that can predict the occurrence of low blood pressure during surgery shortly before it occurs. Studies have already demonstrated the effectiveness of HPI in various operations, where hypotension is defined as a mean arterial blood pressure < 65mmHg for at least 1 minute. To our knowledge, the low blood pressure prediction index has not yet been investigated for the prevention of low blood pressure in shoulder surgery in the beach chair position.
Read more
The HPI is built into a monitor that is switched on in addition to the standard monitoring for monitoring blood pressure, pulse, saturation, among other things. The monitor gives a signal when an episode of low blood pressure will occur within 15 minutes. This gives the anesthesiologist the opportunity to anticipate in time so that the occurrence of low blood pressure can be avoided.
Goal The aim of this study is to evaluate the efficacy of the HPI in predicting and reducing the incidence of hypotension during shoulder surgery in the beach chair position.
Procedure A total of 144 patients will participate in this study. Patients will be randomized to the intervention group or the control group according to a 1:1 allocation. In addition to standard monitoring, the HPI monitor will be turned on for all patients. For patients in the control group, the HPI monitor screen will be blinded and the alarms muted.
Patients between 18 and 85 years of age with a BMI ≤ 40 kg/m2 undergoing elective shoulder surgery are eligible for the study.
- Conditions
- Hypotension During Surgery
- Being tested
- Acumen Hypotension prediction Index software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen Hypotension prediction Index softwareDevice
In the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor).
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | In the blinded HPI group (the control group) the arterial waveform and pressure will be presented on a Philips patient monitor (the standard monitor), while the display of the hemosphere monitor shall be covered and the alarms will be silenced. |
| intervention group | Experimental | In the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor). Receives: Device: Acumen Hypotension prediction Index software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average MAP< than 65 mmHg
Calculated as depth of hypotension below a MAP of 65 mmHg x time spent below a MAP of 65 mmHg (in minutes) divided by total duration of anesthesia (in minutes))
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geertrui Dewinter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Geertrui Dewinter, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120296
- Sponsor's protocol ID
- GDW 10/2022
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Hypotension Prediction Index on the Prevalence of Intra-operative Hypotension During Shoulder Surgery in Beach Chair: A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06120296
- Acronym / sponsor ID
- GDW 10/2022
- Conditions
- Hypotension During Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Geertrui DewinterUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 7 Nov 2023 (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 beach chair position is the most commonly used position during shoulder surgery and offers the surgeon numerous advantages over the lateral decubitus position. However, the beach chair position can also lead to hemodynamic changes, including hypotension and cerebral hypoperfusion. It is therefore the anesthesiologist's job to prevent hypotension during the procedure.
The Acumen Hypotension Predictor Index or HPI for short is a software program that can predict the occurrence of low blood pressure during surgery shortly before it occurs. Studies have already demonstrated the effectiveness of HPI in various operations, where hypotension is defined as a mean arterial blood pressure < 65mmHg for at least 1 minute. To our knowledge, the low blood pressure prediction index has not yet been investigated for the prevention of low blood pressure in shoulder surgery in the beach chair position.
The HPI is built into a monitor that is switched on in addition to the standard monitoring for monitoring blood pressure, pulse, saturation, among other things. The monitor gives a signal when an episode of low blood pressure will occur within 15 minutes. This gives the anesthesiologist the opportunity to anticipate in time so that the occurrence of low blood pressure can be avoided.
Goal The aim of this study is to evaluate the efficacy of the HPI in predicting and reducing the incidence of hypotension during shoulder surgery in the beach chair position.
Procedure A total of 144 patients will participate in this study. Patients will be randomized to the intervention group or the control group according to a 1:1 allocation. In addition to standard monitoring, the HPI monitor will be turned on for all patients. For patients in the control group, the HPI monitor screen will be blinded and the alarms muted.
Patients between 18 and 85 years of age with a BMI ≤ 40 kg/m2 undergoing elective shoulder surgery are eligible for the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –In the blinded HPI group (the control group) the arterial waveform and pressure will be presented on a Philips patient monitor (the standard monitor), while the display of the hemosphere monitor shall be covered and the alarms will be silenced. |
| intervention group | Experimental | Device: Acumen Hypotension prediction Index softwareIn the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI < 40 kg/m2
- Patient can give informed consent
- ASA I-IV
- Invasive blood monitoring
- General anesthesia combined with interscalene block
Key exclusion criteria (7 listed)
- - Refusal of participation
- Hypotension before surgery (MAP< 65 mmHg)
- History of stroke
- Dementia
- Contra-indication for interscalene block
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 Hypotension prediction Index softwareIn the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor). | Device | intervention group |
Primary outcome
Time-weighted average MAP< than 65 mmHg
Time frame: during surgery
Calculated as depth of hypotension below a MAP of 65 mmHg x time spent below a MAP of 65 mmHg (in minutes) divided by total duration of anesthesia (in minutes))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen Hypotension prediction Index software in people with Hypotension During Surgery, run by Geertrui Dewinter at 1 site in Belgium.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average MAP< than 65 mmHg (time frame: during 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 7 Nov 2023.