The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension
- Sponsor
- Jakub Szrama
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- TWA Mean Arterial Pressure (MAP) < 65 mmHg
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Jakub Szrama
Principal Investigator
Poznan University of Medical Sciences
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
Outcomes
Primary Outcomes
TWA Mean Arterial Pressure (MAP) < 65 mmHg
Time Frame: 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 Outcomes
- TWA - MAP < 55 mmHg(From the beginning of the anesthesia to the end of anesthesia)
- TWA - MAP < 60 mmHg(From the beginning of the anesthesia to the end of anesthesia)
- 30 day mortality(30 days)
- 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)