Neurological MorbidityNCT04956835
The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
An observational study of Neurological Morbidity and Surgical Complication, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neurological Morbidity, Surgical Complication, Anesthesia Morbidity
- How many people
- 750 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery at a neurosurgical department either elective or emergency surgery
Who may be able to join
- Patients undergoing surgery at a neurosurgical department
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
Lasse Dührsen, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Hambrug, 20246
Richard Drexler, MD, r.drexler@uke.de
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications according to Clavien-Dindo classification
Grade 0 to V (0 no complication, V death)
Measured: 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)
Measured: within two weeks after surgery
Neurological status
classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within two weeks after surgery
In-hospital mortality
Death of the patient
Measured: within two weeks after surgery
Secondary outcomes (3)
Length of ICU stay
Measured: within two weeks after surgery
Length of hospital stay
Measured: within two weeks after surgery
Readmission rate
Readmission to hospital after discharge
Measured: within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurological MorbidityStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Drexler, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Richard Drexler, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956835
- Sponsor's protocol ID
- CINS
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, 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.
PubMed 32843333Drexler 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.
PubMed 37407852
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of the Classification of Intraoperative Adverse Events (ClassIntra) for Neurosurgical Procedures
- ClinicalTrials.gov ID
- NCT04956835
- Acronym / sponsor ID
- CINS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery at a neurosurgical department either elective or emergency surgery
Key inclusion criteria (1 listed)
- Patients undergoing surgery at a neurosurgical department
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications according to Clavien-Dindo classification
Time frame: within two weeks after surgery
Grade 0 to V (0 no complication, V death)
Comprehensive Complication Index
Time frame: within two weeks after surgery
Based on Clavien-Dindo classification with a scale from 0 to 100 (0 no complication, 100 death)
Neurological status
Time frame: within two weeks after surgery
classified to NANO scale, NIHSS, modified Rankin Scale, Glasgow Outcome Scale
Neurological outcome (NANO scale)
Time frame: 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)
Neurological outcome (NIHSS)
Time frame: 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)
Neurological outcome (mRS)
Time frame: within two weeks after surgery
according to modified Rankin Scale with a scale from 0 to 6 (0 no symptoms, 6 dead)
In-hospital mortality
Time frame: within two weeks after surgery
Death of the patient
3 secondary outcomes
Length of ICU stay
Time frame: within two weeks after surgery
Length of hospital stay
Time frame: within two weeks after surgery
Readmission rate
Time frame: within 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Background: PubMed 32843333Dell-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.
- Derived from this study: PubMed 37407852Drexler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lasse Dührsen, MD contact
Richard Drexler, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Morbidity and Surgical Complication, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Drexler, MD (+4915222816461, r.drexler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications according to Clavien-Dindo classification (time frame: within two weeks after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.