Health TrialsbyHealthPanel

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

ConditionsHypotensionHead and Neck CancerPerioperative ComplicationPostoperative Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJakub Szrama

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients qualified to head and neck free flap surgery

Written informed consent

Disqualifiers

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 %

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypotension Prediction Index

    Device

    Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: Standard Therapy GroupNo intervention 0 interventions
Group B: Hypotension Prediction Index GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

TWA Mean Arterial Pressure (MAP) < 65 mmHg

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

Time frame
From the beginning of the anesthesia to the end of anesthesia

Secondary outcomes

1

TWA - MAP < 60 mmHg

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

Time frame
From the beginning of the anesthesia to the end of anesthesia
2

TWA - MAP < 55 mmHg

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

Time frame
From the beginning of the anesthesia to the end of anesthesia
3

30 day mortality

30 day mortality

Time frame
30 days
4

Length of hospitalisation

Length of hospitalisation

Time frame
From date of randomisation to the date of hospital discharge or date of death, whichever came first, assesed up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jakub Szrama

Lead sponsor

Poznan University of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov
Apply now