PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)

NCT07421882 | Not Yet Recruiting

• 1 other identifier: PRECEDENCE 1.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.

Conditions

Out-Of-Hospital Cardiac Arrest; Cardiopulmonary Resuscitation; Death, Sudden, Cardiac; Therapeutic Hypothermia

Keywords

Return of Spontaneous Circulation

Outcome Measures

Primary Outcomes (6)

• Recruitment feasibility

  Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM

  Through study completion, anticipated to be one year

• Intervention feasibility

  Proportion of recruited OHCA patients receiving the TTM protocol as intended

  Through study completion, anticipated to be one year

• Proportion of cases with complete adherence of workflow and case report forms

  Adherence of paramedics to workflow and case report forms

  Through study completion, anticipated to be one year

• Acceptability of Intervention Measure (AIM)

  Paramedic acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). The AIM consists of a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater acceptability of the intervention. Range score between 4 to 20.

  Time frame within 3 months of case recruitment

• Intervention Appropriateness Measure (IAM)

  Perceived appropriateness of the intervention will be evaluated using the validated Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater perceived fit and relevance of the intervention for prehospital care. Range score between 4 to 20.

  Time frame within 3 months of case recruitment

• Feasibility of Intervention Measure (FIM) scores

  Feasibility of implementing the intervention in the operational prehospital setting will be assessed using the validated Feasibility of Intervention Measure (FIM). The FIM comprises 4 items rated on a 5-point Likert scale, with higher scores indicating greater perceived feasibility. Range score between 4 to 20.

  Time frame within 3 months of case recruitment

Secondary Outcomes (3)

• Proportion of Eligible OHCA Patients Receiving Hospital TTM

  6 hours

• Time to Achieve Target Core Temperature After ROSC

  12 hours

• Good Neurological Outcome at Hospital Discharge

  To hospital discharge, with an average of 30 days

Other Outcomes (3)

• Incidence of Overshoot Cooling (<33°C)

  72 hours

• Incidence of Hemodynamically Significant Bradyarrhythmias

  72 hours

• Incidence of Skin Injury Related to Cooling Device

  72 hours

Study Arms (1)

Pre-hospital Targeted Temperature Management

EXPERIMENTAL

Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) and meet inclusion criteria will receive early targeted temperature management (TTM) initiated in the pre-hospital setting by Singapore Civil Defence Force (SCDF) paramedics. Cooling is delivered using the CarbonCool® surface cooling vest, applied immediately after ROSC and maintained during transport to the receiving hospital. Upon hospital arrival, a 1-for-1 vest exchange is performed in the Emergency Department before continuation of standard post-cardiac arrest care.

Device: CarbonCool® Cooling Vest

Interventions

CarbonCool® Cooling Vest DEVICE

The CarbonCool® vest is a power-free, thermoplastic polyurethane (TPU) surface cooling device containing a proprietary carbon-based cooling medium capable of high heat exchange (35 W/mK). It is designed for rapid pre-hospital application and continuous cooling during patient transport.

Pre-hospital Targeted Temperature Management

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest (OHCA) of any rhythm attended by Singapore Civil Defence Force (SCDF) paramedics.
• Return of spontaneous circulation (ROSC) achieved in the pre-hospital setting.
• Age ≥16 years and ≤80 years.
• Patient remains comatose after ROSC, with Glasgow Coma Scale (GCS) ≤8.

You may not qualify if:

• Age \>80 years.
• Traumatic cause of cardiac arrest.
• Tympanic temperature \<34°C at time of assessment.
• Pregnant females.
• Termination of resuscitation in the Emergency Department.
• Withdrawal of life support within 24 hours of Coronary Care Unit (CCU) admission.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore Civil Defence Force: collaborator
• National University Heart Centre, Singapore: collaborator

Study Sites (1)

National University Heart Centre, Singapore (NUHCS)

Singapore, 119074, Singapore

Location

Related Publications (8)

• Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10.

  PMID: 20123673 BACKGROUND

• Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

  PMID: 24237006 BACKGROUND

• Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.

  PMID: 34133859 BACKGROUND

• Herzog CA, Ma JZ, Collins AJ. Long-term outcome of renal transplant recipients in the United States after coronary revascularization procedures. Circulation. 2004 Jun 15;109(23):2866-71. doi: 10.1161/01.CIR.0000129317.12580.68. Epub 2004 May 24.

  PMID: 15159290 BACKGROUND

• Anthanont P, Jensen MD. Does basal metabolic rate predict weight gain? Am J Clin Nutr. 2016 Oct;104(4):959-963. doi: 10.3945/ajcn.116.134965. Epub 2016 Aug 31.

  PMID: 27581474 BACKGROUND

• Yap LG, Shahidah N, Pothiawala S, et al. Novel wearable cooling device for early initiation of targeted temperature management in the Emergency Department. J Emerg Crit Care Med. 2020;4:5598.

  BACKGROUND

• Sayad A, Omrani MD, Solgi G, Noroozi R, Arsang-Jang S, Inoko H, Taheri M. Interleukin 7 Receptor Alpha Gene Variants Are Correlated with Gene Expression in Patients with Relapsing-remitting Multiple Sclerosis. Iran J Allergy Asthma Immunol. 2017 Aug;16(4):338-346.

  PMID: 28865414 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shir Lynn Lim, MBBS

CONTACT

+65 91760383; shir.lynn.lim@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Masking of participants, care providers, and outcome assessors is not feasible due to the visible and operational nature of the cooling intervention in the pre-hospital environment. All analyses will be performed by the research team using de-identified data to minimize potential assessment bias.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study design to evaluate the feasibility of implementing pre-hospital targeted temperature management (TTM) using a wearable cooling vest compared with standard pre-hospital care. Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) are assigned to the intervention (CarbonCool® vest) based on predefined clinical eligibility and operational criteria. They will be compared against historical controls as well as eligible patients (by inclusion/exclusion criteria) managed by EMS from Divisions 1 to 3. Both groups are prospectively observed for safety, and clinical outcomes.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)