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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Germany1 site
  • University Clinic Giessen

    Giessen, Hesse, 35392

Other trials in Germany

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
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 groups in NCT04151264
Study groupRoleWhat they receive
Control ArmNo interventionblinded HPI monitoring
Intervention ArmActive comparatorHPI 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.

  1. 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)
  1. 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

  2. Changes of catecholamine management

    Dosage of vasopressors and inotropes (in μg)

    Measured: until 4 hours after the end of surgery

  3. Duration of surgery

    cut-seam time

    Measured: up to 24 hours

  4. Fluid balance

    blood loss and urin output in ml

    Measured: until 4 hours after the end of surgery

  5. 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.

  1. First posted5 Nov 2019
  2. Study start30 May 2020
  3. Primary completion1 Jun 2024
  4. Study completion1 Dec 2024

Resources

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)
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 19934864
  • Monk 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 15616043
  • Bijker 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 22277949
  • Ali 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

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.

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