Hypotension During SurgeryNCT05615168
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
A study testing "Acumen IQ" guided hemodynamic optimization and "Flotrac" guided hemodynamic optimization in people with Hypotension During Surgery, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- "Acumen IQ" guided hemodynamic optimization and "Flotrac" guided hemodynamic optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2022to 30 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age
- patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus)
- planned thoracotomy and intraoperative period of one lung ventilation
- planned postoperative admission to the ICU
Who cannot join
- persistent atrial fibrillation
- structural heart defects (shunting or moderate to severe valvular anomalies)
- preoperative serum hemoglobin levels < 120 g/L
- severe heart failure classified as New York Heart Association (NYHA) grade IV
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.
- Conditions
- Hypotension During Surgery
- Being tested
- "Acumen IQ" guided hemodynamic optimization, "Flotrac" guided hemodynamic optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Acumen IQ" guided hemodynamic optimizationDiagnostic test
Hypotension prediction index (HPI) available with the Edwards "Acumen IQ" sensor will be used as an early warning system and a "diagnostic screen" will be used to guide therapeutic interventions.
"Flotrac" guided hemodynamic optimizationDiagnostic test
Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor.
| Study group | Role | What they receive |
|---|---|---|
| AcumenIQ - HPI guided hemodynamic optimization | Experimental | HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors) Receives: Diagnostic Test: "Acumen IQ" guided hemodynamic optimization |
| Flotrac - conventional GDT guided hemodynamic optimization | Active comparator | GDT guided hemodynamic optimization - MAP > 65 mmHg, CI ≥ 2.4 l/min/m2, SVI ≥ 30 ml/beat/m2 and SVRI 1700-2400 dyn·s·cm-5/m2 Receives: Diagnostic Test: "Flotrac" guided hemodynamic optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time weighted average of area under hypotensive threshold
Measured: During surgery
Secondary outcomes (2)
Cumulative duration of hypotension
Measured: During surgery
Number of hypotensive events
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 posted14 Nov 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Šribar, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615168
- Sponsor's protocol ID
- 2022/1807-03
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will share anonymized data after article publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05615168
- Acronym / sponsor ID
- 2022/1807-03
- Conditions
- Hypotension During Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 14 Nov 2022 (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.
Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcumenIQ - HPI guided hemodynamic optimization | Experimental | Diagnostic Test: "Acumen IQ" guided hemodynamic optimizationHPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors) |
| Flotrac - conventional GDT guided hemodynamic optimization | Active comparator | Diagnostic Test: "Flotrac" guided hemodynamic optimizationGDT guided hemodynamic optimization - MAP > 65 mmHg, CI ≥ 2.4 l/min/m2, SVI ≥ 30 ml/beat/m2 and SVRI 1700-2400 dyn·s·cm-5/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 years of age
- patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus)
- planned thoracotomy and intraoperative period of one lung ventilation
- planned postoperative admission to the ICU
Key exclusion criteria (4 listed)
- persistent atrial fibrillation
- structural heart defects (shunting or moderate to severe valvular anomalies)
- preoperative serum hemoglobin levels < 120 g/L
- severe heart failure classified as New York Heart Association (NYHA) grade IV
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 IQ" guided hemodynamic optimizationHypotension prediction index (HPI) available with the Edwards "Acumen IQ" sensor will be used as an early warning system and a "diagnostic screen" will be used to guide therapeutic interventions. | Diagnostic test | AcumenIQ - HPI guided hemodynamic optimization |
| "Flotrac" guided hemodynamic optimizationTherapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor. | Diagnostic test | Flotrac - conventional GDT guided hemodynamic optimization |
Primary outcome
Time weighted average of area under hypotensive threshold
Time frame: During surgery
2 secondary outcomes
Cumulative duration of hypotension
Time frame: During surgery
Number of hypotensive events
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided. Will share anonymized data after article publication
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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.
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?
A study testing "Acumen IQ" guided hemodynamic optimization and "Flotrac" guided hemodynamic optimization in people with Hypotension During Surgery, run by University Hospital Dubrava at 1 site in Croatia.
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: finished, as of the sponsor's last update on 14 Nov 2022. 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 Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time weighted average of area under hypotensive threshold (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 14 Nov 2022.