Clinical trial NCT02803112: Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy
Official title: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injuries, Traumatic
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Traumatic brain injury patients undergoing an emergent craniotomy at our institution (a tertiary referral academic teaching hospital in Leuven, Belgium).

Brief summary: The investigators aim to retrospectively map the delays in the acute care of traumatic brain injury patients necessitating emergent craniotomies.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Temporal delay between emergency call and the surgical skin incision.
timeFrame: From the trauma onset until 24 hours after the trauma onset.
Secondary outcomes:
measure: Temporal delay between emergency call and arrival at our emergency department.
timeFrame: From the trauma onset until 24 hours after the trauma onset.
measure: Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.
timeFrame: From the trauma onset until 24 hours after the trauma onset.
measure: Temporal delay between acquisition of the first head CT slice and arrival in the operating room.
timeFrame: From the trauma onset until 24 hours after the trauma onset.
measure: Glasgow Outcome Scale
timeFrame: 6 months after the trauma
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bart Depreitere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: