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Recruiting NCT05738603

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

No phase Interventional Hypotension Head and Neck Cancer Perioperative Complication Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypotension Prediction Index.
Who it may be relevant to
Registry conditions: Hypotension, Head and Neck Cancer, Perioperative Complication, Postoperative Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Hypotension Prediction Index
    Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Primary outcome measures

  • TWA Mean Arterial Pressure (MAP) < 65 mmHg [Time frame: From the beginning of the anesthesia to the end of anesthesia]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Poland · 1 center
  • Department of Anesthesiology, Intensive Therapy and Pain Management — Poznan

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. PMID 17667564
  • Gu 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. PMID 29429638
  • Wijnberge 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/ja PMID 32065827
  • Maheshwari 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. PMID 32960954
  • Grundmann 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. PMID 34322869
  • Szrama 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. PMID 40141745

Identifiers

NCT: NCT05738603 · 560/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗