Pre-hospital and Intra-hospital Temporal Delays in Patients Requiring Emergent Trauma Craniotomy

Brain Injuries, Traumatic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02803112
• Other study ID #: S59232
• Status: Active, not recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 13, 2016
• Start date: February 2010
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Intervention

Procedure:
• Emergent craniotomy for traumatic brain injury
Emergent craniotomy for traumatic brain injury (either for removal of an epidural hematoma, subdural hematoma, intraparenchymal hematoma or decompressive craniectomy).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporal delay between emergency call and the surgical skin incision.	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.	No
Secondary	Temporal delay between emergency call and arrival at our emergency department.	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.	No
Secondary	Temporal delay between arrival at our emergency department and acquisition of the first head CT slice.	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.	No
Secondary	Temporal delay between acquisition of the first head CT slice and arrival in the operating room.	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.	No
Secondary	Glasgow Outcome Scale	Glasgow Outcome Scale, acquired by a telephone questionnaire, at 6 months after the trauma	6 months after the trauma	No