Anesthesia Clinical Trial
Official title:
Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative and Postoperative Hypotension During Extended Surgical Procedures in ENT- and OM-Surgery
Verified date | November 2023 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - extensive surgery in the head and neck area - Age = 18 years Exclusion Criteria: - Participation in another interventional study - Pregnancy and nursing mothers - Surgery without controlled ventilation - Contraindication to invasive arterial pressure measurement - Renal insufficiency KDIGO stage = 3 - Congenital coagulation disorder |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Giessen | Gießen | Hessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen | Edwards Lifesciences |
Germany,
Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320. — View Citation
Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930. — View Citation
Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number (n) of intraoperative and postoperative hypotension | MAP below 65 mmHg for more than one minute in ventilated patients | until 4 hours after the end of surgery | |
Secondary | Applied volume in ml | Amount of applied infusion volume (crystalloids, colloids, blood products and blood) in ml | until 4 hours after the end of surgery | |
Secondary | Changes of catecholamine management | Dosage of vasopressors and inotropes (in µg) | until 4 hours after the end of surgery | |
Secondary | Duration of surgery | cut-seam time | up to 24 hours | |
Secondary | Fluid balance | blood loss and urin output in ml | until 4 hours after the end of surgery | |
Secondary | Hospital length of stay | Duration of stay in hospital | up to 18 month |
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