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

Sponsor

Jakub Szrama (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05738603

Collaborator

(none)

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotension Head and Neck Cancer Perioperative Complication Postoperative Complications	Device: Hypotension Prediction Index	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Single (Participant)

Masking Description:

The studied patients will be blinded to the enrolled group.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Therapy Group The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring.
Experimental: Hypotension Prediction Index Group 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.	Device: Hypotension Prediction Index Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Arm

Intervention/Treatment

No Intervention: Standard Therapy Group

The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring.

Experimental: Hypotension Prediction Index Group

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.

Device: Hypotension Prediction Index

Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Outcome Measures

Primary Outcome Measures

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

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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