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NCT Number: NCT05738603

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Complication Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients qualified to head and neck free flap surgery
  • Written informed consent

Exclusion criteria

  • 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

Treatment and study plan

Hypotension prediction index

Device

Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Primary outcomes

  1. 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

Secondary outcomes

  1. TWA - MAP < 60 mmHg

    Time frame: From the beginning of the anesthesia to the end of anesthesia

    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

  2. TWA - MAP < 55 mmHg

    Time frame: From the beginning of the anesthesia to the end of anesthesia

    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

  3. 30 day mortality

    Time frame: 30 days

    30 day mortality

  4. 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

    Length of hospitalisation

Study contacts

Contact information is provided by the study sponsor or research team.

Jakub Szrama, Ph.D.

CONTACT

[email protected]

+48 618691856 ext. +48

Sponsors and collaborators

Lead sponsor

Jakub Szrama

Other

Registry information

Official study title

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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