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

Head and Neck Cancer Clinical Trial

Official title:

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738603
• Other study ID #: 560/22
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Poznan University of Medical Sciences
• Contact: Jakub Szrama, Ph.D.
• Phone: +48 618691856
• Email: jakub.szrama[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypotension
• Perioperative Complication
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Anesthesiology, Intensive Therapy and Pain Management	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Jakub Szrama

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TWA Mean Arterial Pressure (MAP) < 65 mmHg	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	From the beginning of the anesthesia to the end of anesthesia
Secondary	TWA - MAP < 60 mmHg	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	From the beginning of the anesthesia to the end of anesthesia
Secondary	TWA - MAP < 55 mmHg	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	From the beginning of the anesthesia to the end of anesthesia
Secondary	30 day mortality	30 day mortality	30 days
Secondary	Length of hospitalisation	Length of hospitalisation	From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months