HypotensionNCT05738603
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.
A study testing Hypotension Prediction Index in people with Hypotension and Head and Neck Cancer, run by Jakub Szrama at 1 site in Poland.
Trial summary
The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Head and Neck Cancer, Perioperative Complication
- What is being tested?
- Hypotension Prediction Index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients qualified to head and neck free flap surgery
- Written informed consent
Who cannot join
- Patients under 18 years
- Lack of health insurance
- Pregnancy
- Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
- Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, 61-355
Jakub Szrama, PhD, +48618691856, jakub.szrama@gmail.com
Agata Gradys, PhD, +48618691856, agatagradys@gmail.com
About this study
Official title: The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.
- Conditions
- Hypotension, Head and Neck Cancer, Perioperative Complication, Postoperative Complications
- Being tested
- Hypotension Prediction Index
- Keywords
- Hypotension, Hypotension Prediction Index, Free Flap Transplant, Head and Neck Cancer, Perioperative Complications
- Medical subject headings
- Hypotension, Head and Neck Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction IndexDevice
Hemodynamic perioperative monitoring with the Hypotension Prediction Index
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy Group | No intervention | The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring. |
| Hypotension Prediction Index Group | Experimental | The HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode. Receives: Device: Hypotension Prediction Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
TWA Mean Arterial Pressure (MAP) < 65 mmHg
TWA - MAP < 65 mmHg - time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
Measured: From the beginning of the anesthesia to the end of anesthesia
Secondary outcomes (4)
TWA - MAP < 60 mmHg
time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 60 mmHg x time in minutes spent below MAP of 60 mmHg)/total duration of operation in minutes
Measured: From the beginning of the anesthesia to the end of anesthesia
TWA - MAP < 55 mmHg
time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 55 mmHg x time in minutes spent below MAP of 55 mmHg)/total duration of operation in minutes
Measured: From the beginning of the anesthesia to the end of anesthesia
30 day mortality
30 day mortality
Measured: 30 days
Length of hospitalisation
Length of hospitalisation
Measured: From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Szrama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Szrama, Poznan University of Medical Sciences
- Investigators
- Jakub Szrama, Ph.D., Principal investigator, Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738603
- Sponsor's protocol ID
- 560/22
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
PubMed 17667564Gu WJ, Hou BL, Kwong JSW, Tian X, Qian Y, Cui Y, Hao J, Li JC, Ma ZL, Gu XP. Association between intraoperative hypotension and 30-day mortality, major adverse cardiac events, and acute kidney injury after non-cardiac surgery: A meta-analysis of cohort studies. Int J Cardiol. 2018 May 1;258:68-73. doi: 10.1016/j.ijcard.2018.01.137. Epub 2018 Feb 2.
PubMed 29429638Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
PubMed 32960954Grundmann CD, Wischermann JM, Fassbender P, Bischoff P, Frey UH. Hemodynamic monitoring with Hypotension Prediction Index versus arterial waveform analysis alone and incidence of perioperative hypotension. Acta Anaesthesiol Scand. 2021 Nov;65(10):1404-1412. doi: 10.1111/aas.13964. Epub 2021 Aug 31.
PubMed 34322869Szrama J, Gradys A, Wozniak A, Nowak Z, Bartkowiak T, Lohani A, Zwolinski K, Koszel T, Kusza K. The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery: Protocol of a Prospective Randomized Controlled Trial. Life (Basel). 2025 Mar 4;15(3):400. doi: 10.3390/life15030400.
PubMed 40141745
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05738603
- Acronym / sponsor ID
- 560/22
- Conditions
- Hypotension, Head and Neck Cancer, Perioperative Complication, Postoperative Complications
- Keywords
- Hypotension, Hypotension Prediction Index, Free Flap Transplant, Head and Neck Cancer, Perioperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Jakub SzramaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 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 aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy Group | No intervention | –The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring. |
| Hypotension Prediction Index Group | Experimental | Device: Hypotension Prediction IndexThe HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients qualified to head and neck free flap surgery
- Written informed consent
Key exclusion criteria (5 listed)
- Patients under 18 years
- Lack of health insurance
- Pregnancy
- Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
- Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring
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 |
|---|---|---|
| Hypotension Prediction IndexHemodynamic perioperative monitoring with the Hypotension Prediction Index | Device | Hypotension Prediction Index Group |
Primary outcome
TWA Mean Arterial Pressure (MAP) < 65 mmHg
Time frame: From the beginning of the anesthesia to the end of anesthesia
TWA - MAP < 65 mmHg - time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes
4 secondary outcomes
TWA - MAP < 60 mmHg
Time frame: From the beginning of the anesthesia to the end of anesthesia
TWA - MAP < 55 mmHg
Time frame: From the beginning of the anesthesia to the end of anesthesia
30 day mortality
Time frame: 30 days
Length of hospitalisation
Time frame: From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months
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 3 Aug 2025.
- Background: PubMed 17667564Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
- Background: PubMed 29429638Gu WJ, Hou BL, Kwong JSW, Tian X, Qian Y, Cui Y, Hao J, Li JC, Ma ZL, Gu XP. Association between intraoperative hypotension and 30-day mortality, major adverse cardiac events, and acute kidney injury after non-cardiac surgery: A meta-analysis of cohort studies. Int J Cardiol. 2018 May 1;258:68-73. doi: 10.1016/j.ijcard.2018.01.137. Epub 2018 Feb 2.
- Background: PubMed 32065827Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
- Background: PubMed 32960954Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
- Background: PubMed 34322869Grundmann CD, Wischermann JM, Fassbender P, Bischoff P, Frey UH. Hemodynamic monitoring with Hypotension Prediction Index versus arterial waveform analysis alone and incidence of perioperative hypotension. Acta Anaesthesiol Scand. 2021 Nov;65(10):1404-1412. doi: 10.1111/aas.13964. Epub 2021 Aug 31.
- Derived from this study: PubMed 40141745Szrama J, Gradys A, Wozniak A, Nowak Z, Bartkowiak T, Lohani A, Zwolinski K, Koszel T, Kusza K. The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery: Protocol of a Prospective Randomized Controlled Trial. Life (Basel). 2025 Mar 4;15(3):400. doi: 10.3390/life15030400.
- 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.
Jakub Szrama, Ph.D. principal investigator
Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension Prediction Index in people with Hypotension and Head and Neck Cancer, run by Jakub Szrama at 1 site in Poland.
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 5 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: looking for participants now, as of the sponsor's last update on 3 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 Poland. 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?
Contact Jakub Szrama, Ph.D. (+48 618691856 ext. +48, jakub.szrama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TWA Mean Arterial Pressure (MAP) < 65 mmHg (time frame: From the beginning of the anesthesia to the end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738603, which also lists 6 linked publications.
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 3 Aug 2025.