Clinical trial NCT04151264: Influence of the "Hypotension Probability Index" on Intraoperative and Postoperative Hypotension in ENT- and OM-Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
ENT Disease
Acute Kidney Injury
Anesthesia
Keywords: Hypotension
tumor of the oropharynx
tumor of the nasopharynx
creatinine
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2019-11-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized two arm study with two groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Blood pressure monitoring displays a crucial part of anesthetic management. An intraoperative hypotension (IOH) is an unwanted complication that can occur during an anaesthetization or during the following duration of the surgery. Causes for this can be vasodilatation (e.g. due to medication), loss of blood volume (e.g. bleeding) or lack of inotropy (reduced left ventricular function, e.g. due to medication).

The main high-risk factors for intraoperative hypotension are age of the patient, pre-existing diseases (especially ASA 3 and higher), the duration of surgery, the urgency of the surgery (emergency surgery), antihypertensive long-term medication as well as combined anaesthesia (regional and general anaesthesia).

According to the examined collective, the definition of IOH and the level of training of the performing doctor we can monitor IOH in up to 100% of patients (depending on the data collection). Monk et al. show that the one-year mortality of patients undergoing surgery was elevated to 3.6% for every minute the systolic pressure was less than 80mmHg. Also, the risk of mortality was 1.4 higher if the MAP decreased \<55mmHg. The consequence of IOH can be a critical reduction of the oxygen supply in the organs. Therefore, organs with low tolerance for hypoxia or a high necessity for oxygen are prone to hypotension induced complications. Those include ischemic stroke or myocardial ischemia (especially in patients with preexisting anemia), mostly happening to older or critical ill patients.

The extensive surgeries in ENT- and OM surgery are usually due to tumor diseases. The incidence for hypopharynx carcinoma is between 2-3/10.000 cases each year with an increasing tendency. The peak of this disease is in the 5.-6. decade of life. Causes for this are chronic noxae like alcohol and cigarettes. Numbers show, that the percentage of malignant tumors in the oral cavity and the pharynx in Germany in 2012 were at 3.7% with men and 1.6% with women in the entirety of incidence of malignant tumors. Especially these tumors require a radical resection also in the initial state of the disease which comes along with a long duration of surgery. The operative interventions include a radical resection of the tumor, neck dissection and if necessary a skin flap depending on the state of the tumor, TNM classification and status of lymph nodes. Complications that can occur with these types of surgery are (secondary) bleeding, stenosis, dyspnea, oedema of the mucosa, subcutaneous emphysema, dysphagia and aspiration. Because of the surgical treatment these patients require a postoperative sedation and ventilation. This enables the protection of the respiratory system when patients are at high risk for intra- or postoperative secondary bleeding and/or swelling. Also, the sedation will help not to imperil the success of the intervention (e.g. through coughing, pressure or choking).

The Hypotension Prediction Index (HPI) was developed by Edwards Lifesciences (Irvine, California, USA) and is certified in the US and Europe. As part of the Edwards Acumen Decision Support software suite, the HPI is based on the minimal invasive FloTrac IQ sensor. The HPI indicates the probability of an occurring hypotensive event. The software was developed using 20,000 cases of past patient events. If the upper limit of hypotension is reached, the software will alert the responsible physician.

The main outcome criteria are the numbers (n) and duration in minutes (t \[min\]) of intraoperative and postoperative hypotension. These are defined as MAP below 65 mmHg for more than one minute in ventilated patients with and without the use of HPI.

The secondary objective criteria are the following:

* Assumed reason for hypotension
* Amount of applied infusion volume (crystalloids, colloids, blood products and blood)
* Type and dose of applied vasopressors
* Type and dose of applied inotropic agents
* Acute Kidney Injury Risk Score

Eligibility criteria: 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

Primary outcomes:
measure: number (n) of intraoperative and postoperative hypotension
timeFrame: until 4 hours after the end of surgery
Secondary outcomes:
measure: Applied volume in ml
timeFrame: until 4 hours after the end of surgery
measure: Changes of catecholamine management
timeFrame: until 4 hours after the end of surgery
measure: Duration of surgery
timeFrame: up to 24 hours
measure: Fluid balance
timeFrame: until 4 hours after the end of surgery
measure: Hospital length of stay
timeFrame: up to 18 month
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Clinic Giessen
state: Hessen
Study officials:
affiliation: UKGM Giessen
name: Michael Sander, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.