HypotensionNCT04151264
Influence of the "Hypotension Probability Index" on Intraoperative and Postoperative Hypotension in ENT- and OM-Surgery
A study testing Hypotension probability index (HPI) in people with Hypotension and ENT Disease, run by University of Giessen at 1 site in Germany.
Trial summary
The aim of the project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, ENT Disease, Acute Kidney Injury
- What is being tested?
- Hypotension probability index (HPI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2020to 1 Dec 2024
- 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
- extensive surgery in the head and neck area
- Age ≥ 18 years
Who cannot join
- Participation in another interventional study
- Pregnancy and nursing mothers
- Surgery without controlled ventilation
- Contraindication to invasive arterial pressure measurement
- Renal insufficiency KDIGO stage ≥ 3
- Congenital coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative and Postoperative Hypotension During Extended Surgical Procedures in ENT- and OM-Surgery
The aim of the project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring.
Read the detailed description
Blood pressure monitoring displays a crucial part of anesthetic management. An intraoperative hypotension (IOH) is an unwanted complication that can occur during an anaesthetization or during the following duration of the surgery. Causes for this can be vasodilatation (e.g. due to medication), loss of blood volume (e.g. bleeding) or lack of inotropy (reduced left ventricular function, e.g. due to medication).
The main high-risk factors for intraoperative hypotension are age of the patient, pre-existing diseases (especially ASA 3 and higher), the duration of surgery, the urgency of the surgery (emergency surgery), antihypertensive long-term medication as well as combined anaesthesia (regional and general anaesthesia).
According to the examined collective, the definition of IOH and the level of training of the performing doctor we can monitor IOH in up to 100% of patients (depending on the data collection). Monk et al. show that the one-year mortality of patients undergoing surgery was elevated to 3.6% for every minute the systolic pressure was less than 80mmHg. Also, the risk of mortality was 1.4 higher if the MAP decreased <55mmHg. The consequence of IOH can be a critical reduction of the oxygen supply in the organs. Therefore, organs with low tolerance for hypoxia or a high necessity for oxygen are prone to hypotension induced complications. Those include ischemic stroke or myocardial ischemia (especially in patients with preexisting anemia), mostly happening to older or critical ill patients.
The extensive surgeries in ENT- and OM surgery are usually due to tumor diseases. The incidence for hypopharynx carcinoma is between 2-3/10.000 cases each year with an increasing tendency. The peak of this disease is in the 5.-6. decade of life. Causes for this are chronic noxae like alcohol and cigarettes. Numbers show, that the percentage of malignant tumors in the oral cavity and the pharynx in Germany in 2012 were at 3.7% with men and 1.6% with women in the entirety of incidence of malignant tumors. Especially these tumors require a radical resection also in the initial state of the disease which comes along with a long duration of surgery. The operative interventions include a radical resection of the tumor, neck dissection and if necessary a skin flap depending on the state of the tumor, TNM classification and status of lymph nodes. Complications that can occur with these types of surgery are (secondary) bleeding, stenosis, dyspnea, oedema of the mucosa, subcutaneous emphysema, dysphagia and aspiration. Because of the surgical treatment these patients require a postoperative sedation and ventilation. This enables the protection of the respiratory system when patients are at high risk for intra- or postoperative secondary bleeding and/or swelling. Also, the sedation will help not to imperil the success of the intervention (e.g. through coughing, pressure or choking).
The Hypotension Prediction Index (HPI) was developed by Edwards Lifesciences (Irvine, California, USA) and is certified in the US and Europe. As part of the Edwards Acumen Decision Support software suite, the HPI is based on the minimal invasive FloTrac IQ sensor. The HPI indicates the probability of an occurring hypotensive event. The software was developed using 20,000 cases of past patient events. If the upper limit of hypotension is reached, the software will alert the responsible physician.
The main outcome criteria are the numbers (n) and duration in minutes (t [min]) of intraoperative and postoperative hypotension. These are defined as MAP below 65 mmHg for more than one minute in ventilated patients with and without the use of HPI.
The secondary objective criteria are the following:
- Assumed reason for hypotension
- Amount of applied infusion volume (crystalloids, colloids, blood products and blood)
- Type and dose of applied vasopressors
- Type and dose of applied inotropic agents
- Acute Kidney Injury Risk Score
- Conditions
- Hypotension, ENT Disease, Acute Kidney Injury, Anesthesia
- Being tested
- Hypotension probability index (HPI)
- Keywords
- Hypotension, tumor of the oropharynx, tumor of the nasopharynx, creatinine
- Medical subject headings
- Hypotension, Otorhinolaryngologic Diseases, Acute Kidney Injury, Oropharyngeal Neoplasms, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension probability index (HPI)Device
The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | blinded HPI monitoring |
| Intervention Arm | Active comparator | HPI monitoring to predict hypotension Receives: Device: Hypotension probability index (HPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number (n) of intraoperative and postoperative hypotension
MAP below 65 mmHg for more than one minute in ventilated patients
Measured: until 4 hours after the end of surgery
Secondary outcomes (5)
Applied volume in ml
Amount of applied infusion volume (crystalloids, colloids, blood products and blood) in ml
Measured: until 4 hours after the end of surgery
Changes of catecholamine management
Dosage of vasopressors and inotropes (in μg)
Measured: until 4 hours after the end of surgery
Duration of surgery
cut-seam time
Measured: up to 24 hours
Fluid balance
blood loss and urin output in ml
Measured: until 4 hours after the end of surgery
Hospital length of stay
Duration of stay in hospital
Measured: up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start30 May 2020
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized two arm study with two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Michael Sander, Prof., Study director, UKGM Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151264
- Sponsor's protocol ID
- HPI II
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
PubMed 19934864Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
PubMed 15616043Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
PubMed 22277949Ali Akbari A, Koch C, Schmidt G, Schmermund D, Langer C, Edinger F, Denn SM, Markmann M, Sander M, Habicher M. Artificial intelligence-based predictive hemodynamic monitoring in conjunction with goal-directed therapy reduces duration, frequency, and severity of intraoperative hypotension in major maxillofacial and otolaryngological surgery-a prospective randomized controlled pilot trial. J Anesth Analg Crit Care. 2025 Dec 22;5(1):92. doi: 10.1186/s44158-025-00331-1.
PubMed 41423680
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative and Postoperative Hypotension During Extended Surgical Procedures in ENT- and OM-Surgery
- ClinicalTrials.gov ID
- NCT04151264
- Acronym / sponsor ID
- HPI II
- Conditions
- Hypotension, ENT Disease, Acute Kidney Injury, Anesthesia
- Keywords
- Hypotension, tumor of the oropharynx, tumor of the nasopharynx, creatinine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 30 May 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Nov 2019 (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 project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring.
Detailed description
Blood pressure monitoring displays a crucial part of anesthetic management. An intraoperative hypotension (IOH) is an unwanted complication that can occur during an anaesthetization or during the following duration of the surgery. Causes for this can be vasodilatation (e.g. due to medication), loss of blood volume (e.g. bleeding) or lack of inotropy (reduced left ventricular function, e.g. due to medication).
The main high-risk factors for intraoperative hypotension are age of the patient, pre-existing diseases (especially ASA 3 and higher), the duration of surgery, the urgency of the surgery (emergency surgery), antihypertensive long-term medication as well as combined anaesthesia (regional and general anaesthesia).
According to the examined collective, the definition of IOH and the level of training of the performing doctor we can monitor IOH in up to 100% of patients (depending on the data collection). Monk et al. show that the one-year mortality of patients undergoing surgery was elevated to 3.6% for every minute the systolic pressure was less than 80mmHg. Also, the risk of mortality was 1.4 higher if the MAP decreased <55mmHg. The consequence of IOH can be a critical reduction of the oxygen supply in the organs. Therefore, organs with low tolerance for hypoxia or a high necessity for oxygen are prone to hypotension induced complications. Those include ischemic stroke or myocardial ischemia (especially in patients with preexisting anemia), mostly happening to older or critical ill patients.
The extensive surgeries in ENT- and OM surgery are usually due to tumor diseases. The incidence for hypopharynx carcinoma is between 2-3/10.000 cases each year with an increasing tendency. The peak of this disease is in the 5.-6. decade of life. Causes for this are chronic noxae like alcohol and cigarettes. Numbers show, that the percentage of malignant tumors in the oral cavity and the pharynx in Germany in 2012 were at 3.7% with men and 1.6% with women in the entirety of incidence of malignant tumors. Especially these tumors require a radical resection also in the initial state of the disease which comes along with a long duration of surgery. The operative interventions include a radical resection of the tumor, neck dissection and if necessary a skin flap depending on the state of the tumor, TNM classification and status of lymph nodes. Complications that can occur with these types of surgery are (secondary) bleeding, stenosis, dyspnea, oedema of the mucosa, subcutaneous emphysema, dysphagia and aspiration. Because of the surgical treatment these patients require a postoperative sedation and ventilation. This enables the protection of the respiratory system when patients are at high risk for intra- or postoperative secondary bleeding and/or swelling. Also, the sedation will help not to imperil the success of the intervention (e.g. through coughing, pressure or choking).
The Hypotension Prediction Index (HPI) was developed by Edwards Lifesciences (Irvine, California, USA) and is certified in the US and Europe. As part of the Edwards Acumen Decision Support software suite, the HPI is based on the minimal invasive FloTrac IQ sensor. The HPI indicates the probability of an occurring hypotensive event. The software was developed using 20,000 cases of past patient events. If the upper limit of hypotension is reached, the software will alert the responsible physician.
The main outcome criteria are the numbers (n) and duration in minutes (t [min]) of intraoperative and postoperative hypotension. These are defined as MAP below 65 mmHg for more than one minute in ventilated patients with and without the use of HPI.
The secondary objective criteria are the following:
- Assumed reason for hypotension
- Amount of applied infusion volume (crystalloids, colloids, blood products and blood)
- Type and dose of applied vasopressors
- Type and dose of applied inotropic agents
- Acute Kidney Injury Risk Score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized two arm study with two groups.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –blinded HPI monitoring |
| Intervention Arm | Active comparator | Device: Hypotension probability index (HPI)HPI monitoring to predict hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- extensive surgery in the head and neck area
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Participation in another interventional study
- Pregnancy and nursing mothers
- Surgery without controlled ventilation
- Contraindication to invasive arterial pressure measurement
- Renal insufficiency KDIGO stage ≥ 3
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 probability index (HPI)The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia. | Device | Intervention Arm |
Primary outcome
number (n) of intraoperative and postoperative hypotension
Time frame: until 4 hours after the end of surgery
MAP below 65 mmHg for more than one minute in ventilated patients
5 secondary outcomes
Applied volume in ml
Time frame: until 4 hours after the end of surgery
Changes of catecholamine management
Time frame: until 4 hours after the end of surgery
Duration of surgery
Time frame: up to 24 hours
Fluid balance
Time frame: until 4 hours after the end of surgery
Hospital length of stay
Time frame: up to 18 month
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 30 Mar 2025.
- Background: PubMed 19934864Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
- Background: PubMed 15616043Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
- Background: PubMed 22277949Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
- Derived from this study: PubMed 41423680Ali Akbari A, Koch C, Schmidt G, Schmermund D, Langer C, Edinger F, Denn SM, Markmann M, Sander M, Habicher M. Artificial intelligence-based predictive hemodynamic monitoring in conjunction with goal-directed therapy reduces duration, frequency, and severity of intraoperative hypotension in major maxillofacial and otolaryngological surgery-a prospective randomized controlled pilot trial. J Anesth Analg Crit Care. 2025 Dec 22;5(1):92. doi: 10.1186/s44158-025-00331-1.
- German Cancer RecordLink provided by the sponsor.
- Edwards InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
Michael Sander, Prof. study director
UKGM Giessen
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 probability index (HPI) in people with Hypotension and ENT Disease, run by University of Giessen at 1 site in Germany.
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 6 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 30 Mar 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 Germany. 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?
number (n) of intraoperative and postoperative hypotension (time frame: until 4 hours after the end of surgery). 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 NCT04151264, which also lists 4 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 30 Mar 2025.