Hypothermia in the Trauma Patient - When do Trauma Patien... | NCT01006837

Studies
Hypothermia in the Trauma Patient - When do Trauma Patients Get Cold?

NCT01006837

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Hypothermia

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2014Actual

First Submitted Date

Nov 2, 2009

First Submission Date that Met QC Criteria

Nov 2, 2009

First Posted Date

Nov 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2017

Last Update Posted Date

Feb 14, 2017Actual

Name	Class
Norwegian Air Ambulance Foundation	OTHER
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to analyze changes in core body- and skin temperature during pre-hospital and early in-hospital treatment of multi-traumatized patients. The researchers want to investigate when trauma patients get cold and to what extent.

Detailed Description

Hypothermia is a common finding in severely traumatized patients. Decreases in core temperature during the course of initial evaluation and resuscitation are common, and can contribute to poor outcomes in multi-traumatized patients.

In this study the temperature will be recorded continually with multiple skin probes and an ear-probe from the site of the accident to arrival in the intensive care unit (including time in primary surgery, if any).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Measure	Description	Time Frame
Survival to discharge		one year

Measure	Description	Time Frame
Degree of hypothermia		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

trauma patient with a ISS 9 or above.

Exclusion Criteria:

<12 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients transported to St. Olavs Hospital (Trondheim, Norway), followed by an anesthesiologist from the norwegian air ambulance and taken care of by the trauma team in the emergency room.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eirik Skogvoll, MD, PhD	St. Olavs Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital, department of anesthesia		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26585382	Result	Uleberg O, Eidstuen SC, Vangberg G, Skogvoll E. Temperature measurements in trauma patients: is the ear the key to the core? Scand J Trauma Resusc Emerg Med. 2015 Nov 19;23:101. doi: 10.1186/s13049-015-0178-z.

ID	Term
D007035	Hypothermia
D014947	Wounds and Injuries

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms