CraniotomyeCRANIONCT01987648
eCRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome
An observational study of Craniotomy and Postoperative Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Regarding the postoperative care strategies following elective craniotomy procedures there is little evidence. Many neurosurgical departments prefer these patients to remain intubated and sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in fear of early postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy, Postoperative Complications
- What is being tested?
- Elective Craniotomy Patients
- Type of treatment
- Surgery or procedure
- How many people
- 1,969 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2011to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who 18 years or older,who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery
Who may be able to join
- 18 Years and older
- Elective craniotomy for any mass lesion or vascular lesion
- Early extubation
Who cannot join
- Biopsy only
- Re-operation
- Craniotomy due to infection
- Awake surgery/craniotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-CRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome
Regarding the postoperative care strategies following elective craniotomy procedures there is little evidence. Many neurosurgical departments prefer these patients to remain intubated and sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in fear of early postoperative complications such as rebleeding or seizures. In this prospective observational study the investigators aim to show that early tracheal extubation following elective brain surgery is feasible and safe.
Read the detailed description
Background
Amongst many surgical subspecialties particularly the field of neurosurgery has made major advancements in the last decade in regards to microsurgical techniques such as continuously pushing the boundaries of radical tumor resection while ensuring patient security and functional integrity nonetheless to mention just one aspect. However, once the surgeon has closed up and the patient is transferred to the intensive care or intermediate care unit for observation for the crucial early postoperative hours the brain tissue is exposed to hemodynamic and respirational changes.
Early postoperative bleeding and brain swelling are the most feared complications after elective craniotomy in neurosurgery. Unfortunately, there is no bedside monitoring to diagnose these complications at a very early state. Patients become symptomatic by a clinical neurological deterioration or an early postoperative seizure. Therefore, much attention has been paid to provide a close monitoring and observation of the patient usually at a critical care unit during the first hours after brain surgery.
Although not substantiated by hard evidence, the major postoperative strategies are the following:
- Parameter oriented: Periods of arterial hypertension, hypoventilation with arterial CO2 increase, low oxygen saturation, extensive coughing, pressing, and pain are strictly avoided. In order to achieve this goal the patient remains intubated and sedated during the first hours postoperatively.
- Symptom oriented: The awakened patient is monitored clinically as early as possible for a deterioration of consciousness, seizure or the development of a new neurological deficit. Thus, the patient is extubated in a timely fashion postoperatively.
Evidently, both strategies are opposite to each other, since strategy 1 requires keeping the patient sedated and intubated over a longer period of time and weaning from artificial ventilation is performed at the critical care unit. This hinders early diagnosis of a neurological deterioration and timely action. On the contrary, strategy 2 aims at a very early extubation of the patient immediately after completing the surgical procedure, which exposes the patient to more hemodynamic and cardiopulmonary stress which may lead to a higher likelihood of a secondary neurological injury.
Since, to the best of the investigators' knowledge, there is no prospective data, depending on the philosophy of the neurosurgeon, the anesthetist and the neuro-intensivist one strategy is preferred over another. For this clinical study, the Department of Neurosurgery Berne is conducting a prospective observational study to show that early tracheal extubation following elective brain surgery is feasible and safe.
Objective
The investigators aim to provide prospective data with respect to complications of early extubation and to compare these results to existing data in the literature with the delayed extubation strategy after elective craniotomy. The investigators believe early extubation and continuous clinical monitoring does not coincide with a higher rate of postoperative complications. Furthermore, strategy 2 might even be superior to strategy 1 in that respect. Also, by conducting this clinical trial the investigators hope to get a more profound insight to further improve the postoperative patient management after elective brain surgery.
The primary endpoint is the incidence of significant postoperative intracranial hemorrhage, brain swelling or seizure leading to either surgical intervention or any new, secondary neurological deficit, coma, palliative care or death related to postoperative events.
As a secondary endpoint the investigators will assess the role of routine early postoperative CT imaging before transfer to the ward and surgical drains.
Methods
This clinical study is designed as a prospective monocenter observational trial. Data as defined in a case report form will be collected of patients undergoing elective craniotomy at the departments of neurosurgery of the University Hospitals in Bern. Patient data collection begins at admission and ends at hospital discharge except for a mortality follow-up of 30 days postoperatively. Statistical analysis will be performed as defined in the study protocol.
- Conditions
- Craniotomy, Postoperative Complications
- Being tested
- Elective Craniotomy Patients
- Keywords
- Craniotomy, Postoperative complications, Perioperative care, Postoperative intracerebral hemorrhage, Postoperative seizure
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Craniotomy PatientsProcedure or surgery
Patients who receive an elective craniotomy (no biopsy, no awake surgery, no re-operation)
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Included are all patients who 18 years or older, who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery Receives: Procedure: Elective Craniotomy Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: 48 hours postoperative
Secondary outcomes (5)
Re-Intubation
Measured: 48 hours postoperative
Mortality
Measured: 30 Days
Emergency CT Scan
Measured: 48 hours postoperative
Re Operation
Measured: 48 hours postoperative
Length of postoperative stay on ICU and IMC
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start1 Nov 2011
- Primary completion28 Sep 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 1,969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph Schär, MD, Principal investigator, Department of Neurosurgery, Inselspital BerneJürgen Beck, Prof., Study chair, Department of Neurosurgery, Inselspital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987648
- Sponsor's protocol ID
- 13-058
- Acronym
- eCRANIO
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2013
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
PubMed 10861145Fadul C, Wood J, Thaler H, Galicich J, Patterson RH Jr, Posner JB. Morbidity and mortality of craniotomy for excision of supratentorial gliomas. Neurology. 1988 Sep;38(9):1374-9. doi: 10.1212/wnl.38.9.1374.
PubMed 3412585Flint AC, Manley GT, Gean AD, Hemphill JC 3rd, Rosenthal G. Post-operative expansion of hemorrhagic contusions after unilateral decompressive hemicraniectomy in severe traumatic brain injury. J Neurotrauma. 2008 May;25(5):503-12. doi: 10.1089/neu.2007.0442.
PubMed 18346002Fukamachi A, Koizumi H, Nagaseki Y, Nukui H. Postoperative extradural hematomas: computed tomographic survey of 1105 intracranial operations. Neurosurgery. 1986 Oct;19(4):589-93. doi: 10.1227/00006123-198610000-00013.
PubMed 3785596Fukamachi A, Koizumi H, Nukui H. Postoperative intracerebral hemorrhages: a survey of computed tomographic findings after 1074 intracranial operations. Surg Neurol. 1985 Jun;23(6):575-80. doi: 10.1016/0090-3019(85)90006-0.
PubMed 3992457Gerald AG. Update on hemostasis: neurosurgery. Surgery. 2007 Oct;142(4 Suppl):S55-60. doi: 10.1016/j.surg.2007.06.030.
PubMed 18019938Kalfas IH, Little JR. Postoperative hemorrhage: a survey of 4992 intracranial procedures. Neurosurgery. 1988 Sep;23(3):343-7. doi: 10.1227/00006123-198809000-00010.
PubMed 3226512Merriman E, Bell W, Long DM. Surgical postoperative bleeding associated with aspirin ingestion. Report of two cases. J Neurosurg. 1979 May;50(5):682-4. doi: 10.3171/jns.1979.50.5.0682.
PubMed 430164Morgan MK, Johnston IH, Hallinan JM, Weber NC. Complications of surgery for arteriovenous malformations of the brain. J Neurosurg. 1993 Feb;78(2):176-82. doi: 10.3171/jns.1993.78.2.0176.
PubMed 8421199Palmer JD, Sparrow OC, Iannotti F. Postoperative hematoma: a 5-year survey and identification of avoidable risk factors. Neurosurgery. 1994 Dec;35(6):1061-4; discussion 1064-5. doi: 10.1227/00006123-199412000-00007.
PubMed 7885549Schar RT, Tashi S, Branca M, Soll N, Cipriani D, Schwarz C, Pollo C, Schucht P, Ulrich CT, Beck J, Z'Graggen WJ, Raabe A. How safe are elective craniotomies in elderly patients in neurosurgery today? A prospective cohort study of 1452 consecutive cases. J Neurosurg. 2020 Apr 24;134(3):1113-1121. doi: 10.3171/2020.2.JNS193460. Print 2021 Mar 1.
PubMed 32330879Schar RT, Fiechter M, Z'Graggen WJ, Soll N, Krejci V, Wiest R, Raabe A, Beck J. No Routine Postoperative Head CT following Elective Craniotomy--A Paradigm Shift? PLoS One. 2016 Apr 14;11(4):e0153499. doi: 10.1371/journal.pone.0153499. eCollection 2016.
PubMed 27077906
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-CRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome
- ClinicalTrials.gov ID
- NCT01987648
- Acronym / sponsor ID
- eCRANIO / 13-058
- Conditions
- Craniotomy, Postoperative Complications
- Keywords
- Craniotomy, Postoperative complications, Perioperative care, Postoperative intracerebral hemorrhage, Postoperative seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,969 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 19 Nov 2013 (estimated)
- 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.
Regarding the postoperative care strategies following elective craniotomy procedures there is little evidence. Many neurosurgical departments prefer these patients to remain intubated and sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in fear of early postoperative complications such as rebleeding or seizures. In this prospective observational study the investigators aim to show that early tracheal extubation following elective brain surgery is feasible and safe.
Detailed description
Background
Amongst many surgical subspecialties particularly the field of neurosurgery has made major advancements in the last decade in regards to microsurgical techniques such as continuously pushing the boundaries of radical tumor resection while ensuring patient security and functional integrity nonetheless to mention just one aspect. However, once the surgeon has closed up and the patient is transferred to the intensive care or intermediate care unit for observation for the crucial early postoperative hours the brain tissue is exposed to hemodynamic and respirational changes.
Early postoperative bleeding and brain swelling are the most feared complications after elective craniotomy in neurosurgery. Unfortunately, there is no bedside monitoring to diagnose these complications at a very early state. Patients become symptomatic by a clinical neurological deterioration or an early postoperative seizure. Therefore, much attention has been paid to provide a close monitoring and observation of the patient usually at a critical care unit during the first hours after brain surgery.
Although not substantiated by hard evidence, the major postoperative strategies are the following:
- Parameter oriented: Periods of arterial hypertension, hypoventilation with arterial CO2 increase, low oxygen saturation, extensive coughing, pressing, and pain are strictly avoided. In order to achieve this goal the patient remains intubated and sedated during the first hours postoperatively.
- Symptom oriented: The awakened patient is monitored clinically as early as possible for a deterioration of consciousness, seizure or the development of a new neurological deficit. Thus, the patient is extubated in a timely fashion postoperatively.
Evidently, both strategies are opposite to each other, since strategy 1 requires keeping the patient sedated and intubated over a longer period of time and weaning from artificial ventilation is performed at the critical care unit. This hinders early diagnosis of a neurological deterioration and timely action. On the contrary, strategy 2 aims at a very early extubation of the patient immediately after completing the surgical procedure, which exposes the patient to more hemodynamic and cardiopulmonary stress which may lead to a higher likelihood of a secondary neurological injury.
Since, to the best of the investigators' knowledge, there is no prospective data, depending on the philosophy of the neurosurgeon, the anesthetist and the neuro-intensivist one strategy is preferred over another. For this clinical study, the Department of Neurosurgery Berne is conducting a prospective observational study to show that early tracheal extubation following elective brain surgery is feasible and safe.
Objective
The investigators aim to provide prospective data with respect to complications of early extubation and to compare these results to existing data in the literature with the delayed extubation strategy after elective craniotomy. The investigators believe early extubation and continuous clinical monitoring does not coincide with a higher rate of postoperative complications. Furthermore, strategy 2 might even be superior to strategy 1 in that respect. Also, by conducting this clinical trial the investigators hope to get a more profound insight to further improve the postoperative patient management after elective brain surgery.
The primary endpoint is the incidence of significant postoperative intracranial hemorrhage, brain swelling or seizure leading to either surgical intervention or any new, secondary neurological deficit, coma, palliative care or death related to postoperative events.
As a secondary endpoint the investigators will assess the role of routine early postoperative CT imaging before transfer to the ward and surgical drains.
Methods
This clinical study is designed as a prospective monocenter observational trial. Data as defined in a case report form will be collected of patients undergoing elective craniotomy at the departments of neurosurgery of the University Hospitals in Bern. Patient data collection begins at admission and ends at hospital discharge except for a mortality follow-up of 30 days postoperatively. Statistical analysis will be performed as defined in the study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Procedure: Elective Craniotomy PatientsIncluded are all patients who 18 years or older, who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who 18 years or older,who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery
Key inclusion criteria (3 listed)
- 18 Years and older
- Elective craniotomy for any mass lesion or vascular lesion
- Early extubation
Key exclusion criteria (4 listed)
- Biopsy only
- Re-operation
- Craniotomy due to infection
- Awake surgery/craniotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective Craniotomy PatientsPatients who receive an elective craniotomy (no biopsy, no awake surgery, no re-operation) | Procedure or surgery | All study participants |
Primary outcome
Morbidity
Time frame: 48 hours postoperative
5 secondary outcomes
Re-Intubation
Time frame: 48 hours postoperative
Mortality
Time frame: 30 Days
Emergency CT Scan
Time frame: 48 hours postoperative
Re Operation
Time frame: 48 hours postoperative
Length of postoperative stay on ICU and IMC
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 10861145Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
- Background: PubMed 3412585Fadul C, Wood J, Thaler H, Galicich J, Patterson RH Jr, Posner JB. Morbidity and mortality of craniotomy for excision of supratentorial gliomas. Neurology. 1988 Sep;38(9):1374-9. doi: 10.1212/wnl.38.9.1374.
- Background: PubMed 18346002Flint AC, Manley GT, Gean AD, Hemphill JC 3rd, Rosenthal G. Post-operative expansion of hemorrhagic contusions after unilateral decompressive hemicraniectomy in severe traumatic brain injury. J Neurotrauma. 2008 May;25(5):503-12. doi: 10.1089/neu.2007.0442.
- Background: PubMed 3785596Fukamachi A, Koizumi H, Nagaseki Y, Nukui H. Postoperative extradural hematomas: computed tomographic survey of 1105 intracranial operations. Neurosurgery. 1986 Oct;19(4):589-93. doi: 10.1227/00006123-198610000-00013.
- Background: PubMed 3992457Fukamachi A, Koizumi H, Nukui H. Postoperative intracerebral hemorrhages: a survey of computed tomographic findings after 1074 intracranial operations. Surg Neurol. 1985 Jun;23(6):575-80. doi: 10.1016/0090-3019(85)90006-0.
- Background: PubMed 18019938Gerald AG. Update on hemostasis: neurosurgery. Surgery. 2007 Oct;142(4 Suppl):S55-60. doi: 10.1016/j.surg.2007.06.030.
- Background: PubMed 3226512Kalfas IH, Little JR. Postoperative hemorrhage: a survey of 4992 intracranial procedures. Neurosurgery. 1988 Sep;23(3):343-7. doi: 10.1227/00006123-198809000-00010.
- Background: PubMed 430164Merriman E, Bell W, Long DM. Surgical postoperative bleeding associated with aspirin ingestion. Report of two cases. J Neurosurg. 1979 May;50(5):682-4. doi: 10.3171/jns.1979.50.5.0682.
- Background: PubMed 8421199Morgan MK, Johnston IH, Hallinan JM, Weber NC. Complications of surgery for arteriovenous malformations of the brain. J Neurosurg. 1993 Feb;78(2):176-82. doi: 10.3171/jns.1993.78.2.0176.
- Background: PubMed 7885549Palmer JD, Sparrow OC, Iannotti F. Postoperative hematoma: a 5-year survey and identification of avoidable risk factors. Neurosurgery. 1994 Dec;35(6):1061-4; discussion 1064-5. doi: 10.1227/00006123-199412000-00007.
- Derived from this study: PubMed 32330879Schar RT, Tashi S, Branca M, Soll N, Cipriani D, Schwarz C, Pollo C, Schucht P, Ulrich CT, Beck J, Z'Graggen WJ, Raabe A. How safe are elective craniotomies in elderly patients in neurosurgery today? A prospective cohort study of 1452 consecutive cases. J Neurosurg. 2020 Apr 24;134(3):1113-1121. doi: 10.3171/2020.2.JNS193460. Print 2021 Mar 1.
- Derived from this study: PubMed 27077906Schar RT, Fiechter M, Z'Graggen WJ, Soll N, Krejci V, Wiest R, Raabe A, Beck J. No Routine Postoperative Head CT following Elective Craniotomy--A Paradigm Shift? PLoS One. 2016 Apr 14;11(4):e0153499. doi: 10.1371/journal.pone.0153499. eCollection 2016.
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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.
Ralph Schär, MD principal investigator
Department of Neurosurgery, Inselspital Berne
Jürgen Beck, Prof. study chair
Department of Neurosurgery, Inselspital Berne
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 Craniotomy and Postoperative Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Dec 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 48 hours postoperative). 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 NCT01987648, which also lists 12 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 8 Dec 2021.