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Trial Title:
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.
NCT ID:
NCT05738603
Condition:
Hypotension
Head and Neck Cancer
Perioperative Complication
Postoperative Complications
Conditions: Official terms:
Head and Neck Neoplasms
Hypotension
Postoperative Complications
Conditions: Keywords:
Hypotension
Hypotension Prediction Index
Free Flap Transplant
Head and Neck Cancer
Perioperative Complications
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
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).
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
The studied patients will be blinded to the enrolled group.
Intervention:
Intervention type:
Device
Intervention name:
Hypotension Prediction Index
Description:
Hemodynamic perioperative monitoring with the Hypotension Prediction Index
Arm group label:
Hypotension Prediction Index Group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Anesthesiology, Intensive Therapy and Pain Management
Address:
City:
Poznań
Zip:
61-355
Country:
Poland
Contact:
Last name:
Jakub Szrama, PhD
Phone:
+48618691856
Email:
jakub.szrama@gmail.com
Contact backup:
Last name:
Agata Gradys, PhD
Phone:
+48618691856
Email:
agatagradys@gmail.com
Start date:
September 1, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Jakub Szrama
Agency class:
Other
Source:
Poznan University of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738603
