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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04956835
• Collaborator: (none)
• Enrollment: 750
• Location: 1
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 124.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Morbidity; Surgical Complication; Anesthesia Morbidity

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 Design

• Study Type: Observational
• Anticipated Enrollment: 750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. Complications according to Clavien-Dindo classification [within two weeks after surgery]

   Grade 0 to V (0 no complication, V death)

2. 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)

3. Neurological status [within two weeks after surgery]

   classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale

4. 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)

5. 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)

6. 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)

7. In-hospital mortality [within two weeks after surgery]

   Death of the patient

Secondary Outcome Measures

1. Length of ICU stay [within two weeks after surgery]

2. Length of hospital stay [within two weeks after surgery]

3. Readmission rate [within 90 days after surgery]

   Readmission to hospital after discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing surgery at a neurosurgical department

Exclusion Criteria:

• Patients under 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg	Hambrug	Germany	20246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

• Principal Investigator: Richard Drexler, MD, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

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, 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.

• Responsible Party: Richard Drexler, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT04956835
• Other Study ID Numbers: CINS
• First Posted: Jul 9, 2021
• Last Update Posted: Jul 9, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 9, 2021