Clinical trial NCT04956835: The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
Official title: The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurological Morbidity
Surgical Complication
Anesthesia Morbidity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery at a neurosurgical department either elective or emergency surgery

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery at a neurosurgical department

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Complications according to Clavien-Dindo classification
timeFrame: within two weeks after surgery
measure: Comprehensive Complication Index
timeFrame: within two weeks after surgery
measure: Neurological status
timeFrame: within two weeks after surgery
measure: Neurological outcome (NANO scale)
timeFrame: within two weeks after surgery
measure: Neurological outcome (NIHSS)
timeFrame: within two weeks after surgery
measure: Neurological outcome (mRS)
timeFrame: within two weeks after surgery
measure: In-hospital mortality
timeFrame: within two weeks after surgery
Secondary outcomes:
measure: Length of ICU stay
timeFrame: within two weeks after surgery
measure: Length of hospital stay
timeFrame: within two weeks after surgery
measure: Readmission rate
timeFrame: within 90 days after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
state: Hambrug
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Richard Drexler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.