NCT02386865

Brief Summary

Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. The purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe TBI. All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome. The logistic regression found the following variables influencing the mortality: respiratory failure (p\<0.0005; OR: 9.369), pupillary response (p\<0.0212, OR: 3.393) and ISS score (p\<0.0001, OR:1.179). A significant (p\<0.0001) increased risk of death was also found for patients with a midline shift \>15 mm. The present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe TBI.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 6, 2015

Last Update Submit

March 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Management

    Interventions, Critical Care Procedures, Blood units, e.g. that were done within the first 3 hours after trauma within the emergency trauma room

    16 years

Secondary Outcomes (1)

  • Glasgow Outcome Scale

    16 years

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

: All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome.

You may qualify if:

  • patients aged 65 years and older and
  • acute severe TBI defined by an Abbreviated Injury Scale (AIS-head) score of ≥ 3 for the head region.

You may not qualify if:

  • oral intubation prior to ED-admission;
  • no details of the time of injury (e.g. chronic subdural hematomas) and
  • any concomitant injuries.
  • Patients who received oral intubation prior to ED-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to TBI induced secondary respiratory failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ostermann RC, Joestl J, Tiefenboeck TM, Lang N, Platzer P, Hofbauer M. Risk factors predicting prognosis and outcome of elderly patients with isolated traumatic brain injury. J Orthop Surg Res. 2018 Nov 3;13(1):277. doi: 10.1186/s13018-018-0975-y.

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 12, 2015

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2012

Last Updated

March 12, 2015

Record last verified: 2015-03