Head and Neck Cancer, Hypotension, Perioperative Complication, Postoperative Complications
Conditions
Keywords
Hypotension, Hypotension Prediction Index, Free Flap Transplant, Head and Neck Cancer, Perioperative Complications
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.
Interventions
Hemodynamic perioperative monitoring with the Hypotension Prediction Index
Sponsors
Jakub Szrama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The studied patients will be blinded to the enrolled group.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Poland
Contacts
Primary ContactJakub Szrama, Ph.D.
Outcome results
None listed