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

NCT ID: NCT03313258

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-05-31

Brief 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.

Conditions

Hypothermia; Trauma; Temperature Change, Body

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Group

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Active Warming Group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Asim Alam

OTHER

Sponsor Role: lead

Responsible Party

Dr. Asim Alam

MD, FRCPC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Asim Alam, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 3656464 (View on PubMed)

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. doi: 10.1097/00005373-198709000-00010.

Reference Type: BACKGROUND

PMID: 3656463 (View on PubMed)

Wang HE, Callaway CW, Peitzman AB, Tisherman SA. Admission hypothermia and outcome after major trauma. Crit Care Med. 2005 Jun;33(6):1296-301. doi: 10.1097/01.ccm.0000165965.31895.80.

Reference Type: BACKGROUND

PMID: 15942347 (View on PubMed)

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. doi: 10.1097/01.ta.0000188647.03665.fd.

Reference Type: BACKGROUND

PMID: 16385283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27095272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23117380 (View on PubMed)

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. doi: 10.1097/01.anes.0000296719.73450.52.

Reference Type: BACKGROUND

PMID: 18156884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25603202 (View on PubMed)

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. doi: 10.1097/01.TA.0000060261.10597.5C.

Reference Type: BACKGROUND

PMID: 12777902 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18575931 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24937305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16875084 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18759678 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23019675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22849694 (View on PubMed)

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):543-549. doi: 10.1213/ANE.0000000000000319.

Reference Type: BACKGROUND

PMID: 25045862 (View on PubMed)

Other Identifiers

RUZIT

Identifier Type: -

Identifier Source: org_study_id