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

NCT04956835 | Unknown DMC

• 1 other identifier: CINS
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Morbidity; Surgical Complication; Anesthesia Morbidity

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Length of ICU stay

  within two weeks after surgery

• Length of hospital stay

  within two weeks after surgery

• Readmission rate

  within 90 days after surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing surgery at a neurosurgical department

You may not qualify if:

• Patients under 18 years

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hambrug, 20246, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 32843333 BACKGROUND

• Drexler R, Ricklefs FL, Pantel T, Gottsche J, Nitzschke R, Zollner C, Westphal M, Duhrsen L. Association of the classification of intraoperative adverse events (ClassIntra) with complications and neurological outcome after neurosurgical procedures: a prospective cohort study. Acta Neurochir (Wien). 2023 Aug;165(8):2015-2027. doi: 10.1007/s00701-023-05672-w. Epub 2023 Jul 5.

  PMID: 37407852 DERIVED

Study Officials

• Richard Drexler, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Drexler, MD

CONTACT

+4915222816461; r.drexler@uke.de

Lasse Dührsen, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 9, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)