C25 D37 C22
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Planned surgery in one of the study-relevant areas of visceral surgery (Upper gastrointestinal tract: esophagus, stomach, duodenum, pancreas, liver and bile duct, small intestine, and colorectal procedures) • Patient age = 18 years • Ability to independently provide written consent for study participation
Exclusion criteria
Exclusion criteria: - Emergency surgical procedure • Pregnancy • History of solid organ transplantation • Presence of a septic condition at the time of the procedure • Pre-existing medical conditions requiring intraoperative controlled hypotension • Lack of capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of visceral organ microperfusion in various situations in the surgical setting: This aims to analyze whether there is a correlation between the parameters of microcirculation measured intraoperatively using spectral imaging and the postoperative occurrence of organ-specific complications. As an example, the intraoperative HSI-based assessment of the mentioned parameters in the context of a pancreatic anastomosis after pancreatic head resection and the postoperative occurrence of pancreatic fistulas should be mentioned. The latter, like all complications, are documented during the postoperative monitoring of patients and graded using common classifications (Clavien-Dindo, CCI, analogous to the OSGPD classification). The principle of this evaluation can be extended to other organs such as hepatic microcirculation in patients undergoing liver resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Analysis: Is there a correlation between intraoperative mean arterial target blood pressure and visceral organ microperfusion? Is there a correlation between intraoperative mean arterial blood pressure and the postoperative occurrence of abdominal complications following visceral surgical procedures? As part of the IMPROVE-multi study conducted by the Department of Anesthesiology at the University Medical Center Hamburg-Eppendorf, a sub-analysis of enrolled patients is conducted. Included patients undergo nocturnal long-term blood pressure monitoring before elective abdominal surgical procedures to determine their individual mean resting blood pressure. In a 1:1 randomization, the determination and adjustment of intraoperative mean arterial target blood pressure (MAP) is then either based on the results of the long-term blood pressure monitoring (intervention group) or according to the clinic's standard (target MAP of 65 mmHg - control group). Following the procedures, data on cardiovascular-associated complications (myocardial infarction, cerebral vascular disorders, pulmonary artery embolisms) are collected for a postoperative period, and their incidence is analyzed in comparison between the intervention and control groups. As part of the HYPER-SPEED study, an exploratory subgroup analysis will now evaluate whether differences in hyperspectral imaging and, consequently, visceral microperfusion can be observed between the two groups of the IMPROVE-multi study. In addition to the evaluation of visceral perfusion, HSI-based measurement of capillary microperfusion is performed by capturing images of the patient's left or right hand. | — |
Countries
Germany
Contacts
UKE