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eCRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome (eCRANIO)

This study is currently recruiting participants.
Verified April 2017 by University Hospital Inselspital, Berne
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987648
First Posted: November 19, 2013
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose
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.

Condition Intervention
Craniotomy Postoperative Complications Procedure: Elective Craniotomy Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: E-CRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 48 hours postoperative ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: November 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Elective Craniotomy Patients
Patients who receive an elective craniotomy (no biopsy, no awake surgery, no re-operation)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 18 Years and older
  • Elective craniotomy for any mass lesion or vascular lesion
  • Early extubation

Exclusion Criteria

  • Biopsy only
  • Re-operation
  • Craniotomy due to infection
  • Awake surgery/craniotomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987648


Contacts
Contact: Ralph Schär, MD 03163122409 ralph.schaer@gmx.ch
Contact: Jürgen Beck, Prof. 03163122409 juergen.beck@insel.ch

Locations
Switzerland
University Berne, Department of Neurosurgery Recruiting
Berne, Switzerland, 3018
Contact: Ralph Schär, MD    03163122409    ralph.schaer@gmx.ch   
Contact: Jürgen Beck, Prof.    03163122409    juergen.beck@insel.ch   
Principal Investigator: Jürgen Beck, Prof. Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Ralph Schär, MD Department of Neurosurgery, Inselspital Berne
Study Chair: Jürgen Beck, Prof. Department of Neurosurgery, Inselspital Berne
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01987648     History of Changes
Other Study ID Numbers: 13-058
First Submitted: November 12, 2013
First Posted: November 19, 2013
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by University Hospital Inselspital, Berne:
Craniotomy
Postoperative complications
Perioperative care
Postoperative intracerebral hemorrhage
Postoperative seizure

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes