Hypotension Prediction Index for free-flap reconstruction in head and neck surgery
Official title: The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Prospective Randomized Controlled Trial.
Run by Poznan University of Medical Sciences · NCT05738603 · Data updated 2026-11-12
This will test whether using the Hypotension Prediction Index reduces episodes of low blood pressure during free-flap reconstruction for people having head and neck cancer surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 206 (estimated) |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan, Poznań) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | December 2026 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT05738603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults scheduled for head and neck free-flap reconstruction who can give written informed consent and do not have exclusions such as persistent atrial fibrillation, severe aortic/mitral stenosis, EF <35%, pregnancy, or lack of insurance.
✕Probably not a fit
Patients under 18, pregnant patients, those without health insurance, or those with persistent atrial fibrillation, severe valvular stenosis, or heart failure with EF <35% are excluded and would not receive potential benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for head and neck free-flap reconstruction will receive intraoperative hemodynamic monitoring using the Hypotension Prediction Index (HPI) to alert clinicians to impending drops in mean arterial pressure. The study aims to lower the time-weighted average of intraoperative hypotension below a MAP threshold of 65 mmHg and to link hypotension episodes with free-flap viability and postoperative complications. Investigators will record intraoperative blood pressure metrics and correlate them with flap function and complication rates after surgery. Patients with major arrhythmias, severe valvular disease, heart failure with ejection fraction below 35%, pregnancy, age under 18, or lacking health insurance are excluded.
Why it matters
Potential benefit: If successful, HPI-guided monitoring could reduce intraoperative hypotension and improve free-flap survival and function after head and neck cancer reconstruction.
How similar studies have gone: HPI-guided hemodynamic monitoring has reduced intraoperative hypotension in other surgical populations, but its specific effect on free-flap outcomes in head and neck reconstruction is novel and unproven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, Poland Recruiting
Study contacts
- Principal investigator: Jakub Szrama, Ph.D. — Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy
- Study coordinator: Jakub Szrama, Ph.D.
- Email: jakub.szrama@gmail.com
- Phone: +48 618691856
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.