Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04956835
Other study ID # CINS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05991453 - Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial N/A
Completed NCT03369197 - Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy N/A
Completed NCT03306914 - Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients N/A
Completed NCT04192045 - Quality of Recovery From Obstetric Anaesthesia - a Multicentre Study
Completed NCT05383417 - No Post Intubation Laryngeal Symptoms N/A
Completed NCT03117894 - PECS-2 for Breast Surgery N/A
Completed NCT03028688 - HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy N/A
Not yet recruiting NCT06287632 - CPAP in Patients With Severe Obesity After Anesthesia N/A
Completed NCT05591105 - Morphine Consumption in the Obese Patients
Not yet recruiting NCT05869578 - Registry of Anesthesia and Perioperative Medicine
Completed NCT05852899 - Evaluation of Preoperative Risk Factors in Children
Completed NCT01680471 - A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery N/A
Recruiting NCT04826627 - Impact of Preoperative Fasting on Intraoperative Glycemic Homeostasis and Enhanced Recovery in Children
Recruiting NCT04483765 - Shock Index, Modified Shock Index and Age-related Shock Index for Predicting Post-spinal Hypotension in Elderly Patients
Completed NCT01740453 - Effect of Interscalene Block on Ventilatory Function Phase 4
Completed NCT03818009 - Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section
Completed NCT04203732 - Evaluation of Anesthetic Techniques in Outpatient Total Joint Replacement Surgery in an Integrated Health Care Delivery System
Completed NCT03044418 - Anesthesia With Endotracheal Laser Tube
Completed NCT03971851 - Validation of a Novel Frailty Index in Surgical Cohorts