Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)

Trauma Clinical Trial

— RUZIT  

Official title:

The Relationship Between the Use of a Continuous a Zero-heat Flux Temperature Monitor on Initial Discharge Hypothermia Rate Among Severely Injured Trauma Patients: a Randomized Controlled Trial. (RUZIT Trial)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03313258
• Other study ID #: RUZIT
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: February 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >18 years of age

• Severely injured trauma patients with a Revised Trauma Score (RTS) = 11 brought into the SHSC TB.

Exclusion Criteria:

• Patients with blast injuries to the face or severe facial trauma will be excluded.

• Major burn patients - as they follow a separate care pathway at SHSC

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Temperature Change, Body
• Trauma
• Wounds and Injuries

Intervention

Device:
• Standard of Care Group
ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is blinded to the care team but not to the research personnel.
• Active Warming Group
ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is un-blinded to everyone so healthcare practitioners will be able to visually detect continuous temperature readings from the ZHF monitor.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Asim Alam

Country where clinical trial is conducted

Canada, 

References & Publications (16)

Bochicchio GV, Napolitano L, Joshi M, Bochicchio K, Meyer W, Scalea TM. Outcome analysis of blood product transfusion in trauma patients: a prospective, risk-adjusted study. World J Surg. 2008 Oct;32(10):2185-9. doi: 10.1007/s00268-008-9655-0. — View Citation

Bochicchio GV, Napolitano L, Joshi M, Bochicchio K, Shih D, Meyer W, Scalea TM. Blood product transfusion and ventilator-associated pneumonia in trauma patients. Surg Infect (Larchmt). 2008 Aug;9(4):415-22. doi: 10.1089/sur.2006.069. — View Citation

Bukur M, Hadjibashi AA, Ley EJ, Malinoski D, Singer M, Barmparas G, Margulies D, Salim A. Impact of prehospital hypothermia on transfusion requirements and outcomes. J Trauma Acute Care Surg. 2012 Nov;73(5):1195-201. doi: 10.1097/TA.0b013e31826fc7d9. — View Citation

Dunne JR, Riddle MS, Danko J, Hayden R, Petersen K. Blood transfusion is associated with infection and increased resource utilization in combat casualties. Am Surg. 2006 Jul;72(7):619-25; discussion 625-6. — View Citation

Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-9. doi: 10.1213/ANE.0000000000000319. — View Citation

Jurkovich GJ, Greiser WB, Luterman A, Curreri PW. Hypothermia in trauma victims: an ominous predictor of survival. J Trauma. 1987 Sep;27(9):1019-24. — View Citation

Lapostolle F, Sebbah JL, Couvreur J, Koch FX, Savary D, Tazarourte K, Egman G, Mzabi L, Galinski M, Adnet F. Risk factors for onset of hypothermia in trauma victims: the HypoTraum study. Crit Care. 2012 Jul 31;16(4):R142. doi: 10.1186/cc11449. — View Citation

Luna GK, Maier RV, Pavlin EG, Anardi D, Copass MK, Oreskovich MR. Incidence and effect of hypothermia in seriously injured patients. J Trauma. 1987 Sep;27(9):1014-8. — View Citation

Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003 May;54(5):898-905; discussion 905-7. — View Citation

Perel P, Clayton T, Altman DG, Croft P, Douglas I, Hemingway H, Hingorani A, Morley KI, Riley R, Timmis A, Van der Windt D, Roberts I; PROGRESS Partnership. Red blood cell transfusion and mortality in trauma patients: risk-stratified analysis of an observational study. PLoS Med. 2014 Jun 17;11(6):e1001664. doi: 10.1371/journal.pmed.1001664. eCollection 2014 Jun. — View Citation

Perlman R, Callum J, Laflamme C, Tien H, Nascimento B, Beckett A, Alam A. A recommended early goal-directed management guideline for the prevention of hypothermia-related transfusion, morbidity, and mortality in severely injured trauma patients. Crit Care. 2016 Apr 20;20(1):107. doi: 10.1186/s13054-016-1271-z. Review. — View Citation

Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. Review. — View Citation

Reynolds BR, Forsythe RM, Harbrecht BG, Cuschieri J, Minei JP, Maier RV, Moore EE, Billiar EE, Peitzman AB, Sperry JL; Inflammation and Host Response to Injury Investigators. Hypothermia in massive transfusion: have we been paying enough attention to it? J Trauma Acute Care Surg. 2012 Aug;73(2):486-91. — View Citation

Shafi S, Elliott AC, Gentilello L. Is hypothermia simply a marker of shock and injury severity or an independent risk factor for mortality in trauma patients? Analysis of a large national trauma registry. J Trauma. 2005 Nov;59(5):1081-5. — View Citation

Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551. — View Citation

Wang HE, Callaway CW, Peitzman AB, Tisherman SA. Admission hypothermia and outcome after major trauma. Crit Care Med. 2005 Jun;33(6):1296-301. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothermic (<36°C) upon discharge from the trauma bay	Proportion of patients who are hypothermic (<36°C) upon discharge from the trauma bay.	Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Secondary	Warming initiatives	Total number of warming initiatives implemented by trauma care team	Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Secondary	Transfused products	Number of transfused blood products	Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Secondary	Length of stay	Number of days patient stayed in hospital	Time of admission to discharge or up to 1 year after admission (whichever comes first)
Secondary	30 day mortality	Alive or deceased at 30 day	Time of admission to discharge or up to 30 days after admission (whichever comes first)