NCT04151264

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

May 30, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

October 14, 2019

Last Update Submit

March 25, 2025

Conditions

HypotensionENT DiseaseAcute Kidney InjuryAnesthesia

Keywords

Hypotensiontumor of the oropharynxtumor of the nasopharynxcreatinine

Outcome Measures

Primary Outcomes (1)

  • number (n) of intraoperative and postoperative hypotension

    MAP below 65 mmHg for more than one minute in ventilated patients

    until 4 hours after the end of surgery

Secondary Outcomes (5)

  • Applied volume in ml

    until 4 hours after the end of surgery

  • Changes of catecholamine management

    until 4 hours after the end of surgery

  • Duration of surgery

    up to 24 hours

  • Fluid balance

    until 4 hours after the end of surgery

  • Hospital length of stay

    up to 18 month

Study Arms (2)

Control Arm

NO INTERVENTION

blinded HPI monitoring

Intervention Arm

ACTIVE COMPARATOR

HPI monitoring to predict hypotension

Device: Hypotension probability index (HPI)

Interventions

Hypotension probability index (HPI)DEVICE

The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • extensive surgery in the head and neck area
  • Age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

  • 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.

    PMID: 19934864BACKGROUND

  • 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.

    PMID: 15616043BACKGROUND

  • 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.

    PMID: 22277949BACKGROUND

  • 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.

    PMID: 41423680DERIVED

Related Links

MeSH Terms

Conditions

HypotensionOtorhinolaryngologic DiseasesAcute Kidney InjuryOropharyngeal NeoplasmsNasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesNasopharyngeal Diseases

Study Officials

  • Michael Sander, Prof.

    UKGM Giessen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized two arm study with two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

November 5, 2019

Study Start

May 30, 2020

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)