The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Morbidity; Neurological Morbidity; Surgical Complication

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.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

• Study Contact: Name: Lasse Dührsen, MD

Study Locations

• Germany
  • Hambrug
    • Hamburg, Hambrug, Germany, 20246
      • Recruiting
      • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at a neurosurgical department either elective or emergency surgery

Description

Inclusion Criteria:

• Patients undergoing surgery at a neurosurgical department

Exclusion Criteria:

• Patients under 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications according to Clavien-Dindo classification	Grade 0 to V (0 no complication, V death)	within two weeks after surgery
Comprehensive Complication Index	Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death)	within two weeks after surgery
Neurological status	classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale	within two weeks after surgery
Neurological outcome (NANO scale)	according to neurological assessment in neuro-oncology (NANO) with a scale from 0 to 23 (0 no neurological deficit, 23 multiple neurological deficits)	within two weeks after surgery
Neurological outcome (NIHSS)	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)	within two weeks after surgery
Neurological outcome (mRS)	according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead)	within two weeks after surgery
In-hospital mortality	Death of the patient	within two weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay		within two weeks after surgery
Length of hospital stay		within two weeks after surgery
Readmission rate	Readmission to hospital after discharge	within 90 days after surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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, Orestis I, 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (ACTUAL): July 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CINS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No