Clinical trial NCT05738603: The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.
Official title: The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension
Head and Neck Cancer
Perioperative Complication
Postoperative Complications
Keywords: Hypotension
Hypotension Prediction Index
Free Flap Transplant
Head and Neck Cancer
Perioperative Complications
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: TWA Mean Arterial Pressure (MAP) < 65 mmHg
timeFrame: From the beginning of the anesthesia to the end of anesthesia
Secondary outcomes:
measure: TWA - MAP < 60 mmHg
timeFrame: From the beginning of the anesthesia to the end of anesthesia
measure: TWA - MAP < 55 mmHg
timeFrame: From the beginning of the anesthesia to the end of anesthesia
measure: 30 day mortality
timeFrame: 30 days
measure: Length of hospitalisation
timeFrame: From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Anesthesiology, Intensive Therapy and Pain Management
Study officials:
affiliation: Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy
name: Jakub Szrama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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/jama.2020.0592.
citation: 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.
citation: 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.