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

Not Applicable

Not yet recruiting

• Conditions: Hypotension; Head and Neck Cancer; Perioperative Complication; Postoperative Complications
• Interventions: Device: Hypotension Prediction Index

• Registration Number: NCT05738603
• Lead Sponsor: Jakub Szrama

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-29
• Last Update Posted: 2024-07-03
• Study Start: 2024-09-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypotension Prediction Index Group	Hypotension Prediction Index	The HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode.

Primary Outcome Measures

Name	Time	Method
TWA Mean Arterial Pressure (MAP) < 65 mmHg	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 Outcome Measures

Name	Time	Method
TWA - MAP < 55 mmHg	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
TWA - MAP < 60 mmHg	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
30 day mortality	30 days	30 day mortality
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	Length of hospitalisation

Trial Locations

Locations (1)

Department of Anesthesiology, Intensive Therapy and Pain Management; 🇵🇱 Poznań, Poland