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

December 7, 2021 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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 Type

Observational

Enrollment (Actual)

1969

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3018
        • University Berne, Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: 48 hours postoperative
48 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 Days
30 Days
Re-Intubation
Time Frame: 48 hours postoperative
48 hours postoperative
Emergency CT Scan
Time Frame: 48 hours postoperative
48 hours postoperative
Re Operation
Time Frame: 48 hours postoperative
48 hours postoperative
Length of postoperative stay on ICU and IMC
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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