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

Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956835
• Other study ID #: CINS
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Richard Drexler, MD
• Phone: +4915222816461
• Email: r.drexler[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing surgery at a neurosurgical department

Exclusion Criteria:

• Patients under 18 years

Related Conditions & MeSH terms

• Anesthesia Morbidity
• Neurological Morbidity
• Surgical Complication

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg	Hambrug

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, Gié O, Goebel B, Hahnloser D, Herbst F, Orestis I, Joller S, Kang S, Martín 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications according to Clavien-Dindo classification	Grade 0 to V (0 no complication, V death)	within two weeks after surgery
Primary	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
Primary	Neurological status	classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale	within two weeks after surgery
Primary	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
Primary	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
Primary	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
Primary	In-hospital mortality	Death of the patient	within two weeks after surgery
Secondary	Length of ICU stay		within two weeks after surgery
Secondary	Length of hospital stay		within two weeks after surgery
Secondary	Readmission rate	Readmission to hospital after discharge	within 90 days after surgery