Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

NCT02353793 | Completed

• 1 other identifier: ReadyHeat
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

Conditions

Hypothermia; Trauma

Keywords

Hypothermia; (Poly) Trauma; Emergency Room; Warming Blanket

Outcome Measures

Primary Outcomes (1)

• Body core temperature at the end of completed emergency room treatment

  Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame \< 60 min is maintained.

  When handing the patient over to the next caring unit (ICU, operating theatre etc.) n most cases an average time frame < 60 min is maintained

Secondary Outcomes (1)

• Body core temperature during emergency room treatment

  Temperature measurement: Admission, after 15, 30, 45 minutes

Study Arms (2)

ReadyHeat® blanket

EXPERIMENTAL

Patient warming with ReadyHeat® blanket

Device: ReadyHeat® blanket

Cotton wool blanket

ACTIVE COMPARATOR

Patient warming with cotton wool blanket

Device: Cotton wool blanket

Interventions

ReadyHeat® blanket DEVICE

Using ReadyHeat® blanket for patient warming

ReadyHeat® blanket

Cotton wool blanket DEVICE

Using cotton wool blanket for patient warming

Cotton wool blanket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room

You may not qualify if:

• Patients \< 18 years
• Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (3)

• Curry N, Davis PW. What's new in resuscitation strategies for the patient with multiple trauma? Injury. 2012 Jul;43(7):1021-8. doi: 10.1016/j.injury.2012.03.014. Epub 2012 Apr 7.

  PMID: 22487163 BACKGROUND

• Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.

  PMID: 18648241 BACKGROUND

• Kapan M, Onder A, Oguz A, Taskesen F, Aliosmanoglu I, Gul M, Tacyildiz I. The effective risk factors on mortality in patients undergoing damage control surgery. Eur Rev Med Pharmacol Sci. 2013 Jun;17(12):1681-7.

  PMID: 23832738 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Wounds and Injuries; Emergencies

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Jan Höcker, M.D.

  Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: February 3, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

DE (1)