Clinical trial NCT04332237: Meta-Analysis Accidental Hypothermia in Trauma
Official title: The Impact of Accidental Hypothermia on Mortality in Trauma Patients Overall and Patients With Traumatic Brain Injury Specifically: A Systematic Review and Meta-Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Trauma
Brain Injuries, Traumatic
Morality
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 776684
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patiens overall and patiens with traumatic brain injury specifically

Brief summary: This is a systematic literature review and meta-analysis investigating the effect of accidental hypothermia on mortality in trauma patients overall and patients with TBI specifically.

Literature search will be performed using the Ovid Medline/PubMed database. Studies comparing the effect of hypothermia vs. normothermia at hospital admission on in-hospital mortality will be included in meta-analysis.

Detailed description: Accidental hypothermia is a known predictor for worse outcomes in trauma patients, but has not been comprehensively assessed in meta-analysis so far. The aim of this systematic review and meta-analysis is to investigate the impact of accidental hypothermia on mortality in trauma patients overall and patients with traumatic brain injury (TBI) specifically.

Literature search will be conducted using the Ovid Medline/PubMed database. The search strategy will be based on the PICOS strategy.

Scientific articles reporting (1) accidental hypothermia in trauma patients overall or patients with TBI specifically, (2) body temperature and time of measurement, and (3) the impact of accidental hypothermia on outcomes will be included in the qualitative review.

Two meta-analyses will be performed including (1) trauma patients overall and (2) patients with TBI specifically. Studies reporting in-hospital mortality of hypothermic and normothermic trauma patients overall or patients with TBI specifically, based on the temperature measured at Emergency Department admission, will be included in meta-analysis. Meta-analysis will be performed using a Mantel-Haenszel random-effects model. The estimated effect size for mortality will be reported as odds ratio (OR) and 95% confidence interval (CI) for each study as well as for the overall cohort.

Eligibility criteria: Inclusion criteria:

* Original scientific articles
* English language
* Study in trauma patients
* Reported body temperature and time of temperature measurement
* Reported impact of accidental hypothermia on outcomes

Exclusion criteria:

* Case reports
* Systematic reviews
* Articles on therapeutic hypothermia

Primary outcomes:
measure: In-hospital mortality
timeFrame: From hospital admission to discharge, expected to be up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospial
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Tobias Haltmeier, MD
role: PRINCIPAL_INVESTIGATOR
References: