- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02803112
Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy
Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy. A 6-year Retrospective Analysis in a Level 1 Trauma Center
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the high incidence of traumatic brain injury (TBI) and the high numbers of emergent craniotomies for TBI performed worldwide, publications reporting on temporal delays in these patients are very scarce. To the best of the investigators' knowledge, there are only 3 publications providing data on the intra-hospital delay and no publications on pre-hospital delay specifically for TBI patients undergoing emergent craniotomies.
The aim of the present study is to retrospectively map delays between the emergency call of the national emergency telephone dispatch to the hospital's medical emergency service (EC) and the surgical skin incision in emergent TBI craniotomies in the investigators' level 1 trauma center and to propose possible measures to improve performance.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- every patient undergoing 1 of 3 surgical procedures ('removal of epidural hematoma'; 'removal of acute subdural hematoma'; and 'decompressive craniectomy'), performed between February 1, 2010 and January 31, 2016, as recorded in the surgical database of our institution.
Exclusion Criteria:
- who had a delayed clinical or radiological deterioration as a surgical indication;
- who did not have traumatic brain injury as the origin of the intracranial abnormalities;
- in whom not all aforementioned temporal or clinical data were readily available from the electronic patient file; and/or
- who were not admitted via our emergency department.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporal delay between emergency call and the surgical skin incision.
Time Frame: From the trauma onset until 24 hours after the trauma onset.
|
Temporal delay (in minutes) between emergency call of the national emergency telephone dispatch to the hospital's medical emergency service and the surgical skin incision during the emergent craniotomy for traumatic brain injury.
|
From the trauma onset until 24 hours after the trauma onset.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporal delay between emergency call and arrival at our emergency department.
Time Frame: From the trauma onset until 24 hours after the trauma onset.
|
Temporal delay (in minutes) between emergency call of the national emergency telephone dispatch to the hospital's medical emergency service and the arrival at the emergency department of our institution.
|
From the trauma onset until 24 hours after the trauma onset.
|
|
Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.
Time Frame: From the trauma onset until 24 hours after the trauma onset.
|
Temporal delay (in minutes) between the arrival at the emergency department of our institution and the acquisition of the first head CT slice.
|
From the trauma onset until 24 hours after the trauma onset.
|
|
Temporal delay between acquisition of the first head CT slice and arrival in the operating room.
Time Frame: From the trauma onset until 24 hours after the trauma onset.
|
Temporal delay (in minutes) between the acquisition of the first head CT slice and arrival in the operating room for emergent trauma craniotomy.
|
From the trauma onset until 24 hours after the trauma onset.
|
|
Glasgow Outcome Scale
Time Frame: 6 months after the trauma
|
Glasgow Outcome Scale, acquired by a telephone questionnaire, at 6 months after the trauma
|
6 months after the trauma
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bart Depreitere, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S59232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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