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Feasibility and Safety of Early Extubation After Elective Brain Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01987648
First received: November 12, 2013
Last updated: June 12, 2014
Last verified: June 2014
  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: Feasibility and Safety of Early Extubation After Elective Craniotomy - a Prospective Observational Single Center Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Morbidity [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-Intubation [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Emergency CT Scan [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
  • Re Operation [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
  • Length of postoperative stay on ICU and IMC [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01987648     History of Changes
Other Study ID Numbers: 13-058
Study First Received: November 12, 2013
Last Updated: June 12, 2014
Health Authority: Switzerland: Internal Review Board Inselspital

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

ClinicalTrials.gov processed this record on November 25, 2014