Awakening Early, Valve Heart Disease
Conditions
Brief summary
Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids. The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.
Interventions
OTHERPost-operative intensive care using volatile sedation
Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..
Sponsors
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Valve reconstruction or valve replacement * Must be capable to giving written consent
Exclusion criteria
* Intolerance to volatile anaesthetics (e.g. malignant hyperthermia) * Severe obstructive pulmonary disease * Extended aortic arch or ascending aorta surgery * Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to extubation | through study completion, an average of 2 days | Time from admission on ICU until awakening and Extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to neurocognitive assessability | through study completion, an average of 2 days | Time from admission on ICU until awake and neurocognitive assessable. |
| Required setup time of the intensive care workplace | through study completion, up to 24 hours | Required setup time of the intensive care workplace to provide volatile or intravenous sedation. |
| Factor related to the course of intensive care: blood loss | through study completion, an average of 24 hours | Measured Postoperative Blood Loss |
| Factor related to the course of intensive care: kidney injury | through study completion, an average of 24 hours | Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria. |
| Factor related to the course of intensive care: acid-base balance | through study completion, an average of 24 hours | Measured serum lactate levels and hypercapnia |
| postoperative nausea and vomiting | through study completion, up to 24 hours | Detection of postoperative nausea and vomiting |
| Factor related to the course of intensive care:cardiovascular medication | through study completion, an average of 24 hours | Required dosage of adrenaline, noradrenaline, vasopressin or milrinone |
| Factors related to the course of operative procedure | through study completion, up to 24 hours | time of the intraoperative procedure including the heart-lung-machine |
| Intra-hospital mortality | through study completion, an average of 7 days | Intra-hospital mortality - Safety outcome |
| Liver failure | through study completion, an average of 7 days | Intra-hospital liver failure - Safety outcome |
| Factor related to the course of intensive care: lung function parameters | through study completion, an average of 24 hours | Required inspiratory oxygen fraction |
Countries
Germany
Outcome results
None listed