Anesthesia Morbidity, Neurological Morbidity, Surgical Complication
Conditions
Brief summary
In the planned study, the ClassIntra score will be assessed after all neurosurgical procedures in the upcoming 6 months and correlated with all pre- and postoperative data. Afterwards, the conclusion will be made, if the ClassIntra score could predict the postoperative course of the patients regarding their neurological and general condition. Furthermore, analyses will be made to develop novel postoperative routines adjusted to the individual ClassIntra score of the patient.
Detailed description
Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. As there are well-defined scores and classifications to describe the postoperative course regarding morbidity, mortality and neurological status, no validated classification for intraoperative quality exists by now. However, Dell-Kuster et al. introduced a novel classification for assessing all intraoperative adverse events: ClassIntra. This classification was developed in a Delphi consensus containing international, interdisciplinary, and validated in a multicentre cohort study across all surgical disciplines. The classification defines intraoperative adverse events as any deviation from the ideal intraoperative course occurring between skin incision and skin closure and contains any event related to surgery and anaesthesia. Depending on the kind of adverse event, the ClassIntra score ranges from 0 (no event) to 5 (intraoperative death). A prospective study with a main focus on neurosurgery covering the whole spectrum of elective and emergency procedures is needed. Hereby, the outcome parameters need to be defined specific for neurosurgical procedures including a preoperative and postoperative neurological status.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing surgery at a neurosurgical department
Exclusion criteria
* Patients under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | within two weeks after surgery | Death of the patient |
| Neurological outcome (NANO scale) | within two weeks after surgery | according to neurological assessment in neuro-oncology (NANO) with a scale from 0 to 23 (0 no neurological deficit, 23 multiple neurological deficits) |
| Neurological outcome (NIHSS) | within two weeks after surgery | according to National Institutes of Health Stroke Scale (0 no stroke symptoms 1-4 minor stroke 5-15 moderate stroke 16-20 moderate to severe stroke 21-42 severe stroke) |
| Neurological outcome (mRS) | within two weeks after surgery | according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead) |
| Complications according to Clavien-Dindo classification | within two weeks after surgery | Grade 0 to V (0 no complication, V death) |
| Comprehensive Complication Index | within two weeks after surgery | Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death) |
| Neurological status | within two weeks after surgery | classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | within two weeks after surgery | — |
| Readmission rate | within 90 days after surgery | Readmission to hospital after discharge |
| Length of hospital stay | within two weeks after surgery | — |
Countries
Germany
Contacts
Primary ContactRichard Drexler, MD
Backup ContactLasse Dührsen, MD
Outcome results
None listed