Out of Hospital Cardiac ArrestNCT01528475
Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors
A study testing Pre-hospital cooling in people with Out of Hospital Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial summary
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- Pre-hospital cooling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
- Age equal to or greater than 18 years
- Defibrillation and/or chest compressions by EMS providers (including fire fighters)
- Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
- Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
- Patient is endotracheally intubated
- SBP equal to or greater than 100 mm Hg (even if needing dopamine)
Who cannot join
- Trauma (including burns) associated with cardiac arrest
- Sepsis or serious infection suspected as cause of cardiac arrest
- Clinical evidence of active severe bleeding
- Suspected hypothermic cardiac arrest
- Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
- Any verbal or written do-not-resuscitate (DNR)
- Obviously pregnant
- Known Prisoner
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Peel Emergency Medical Services
Mississauga, Ontario
Halton Emergency Medical Services
Oakville, Ontario
Toronto Emergency Medical Services
Toronto, Ontario
About this study
Official title: Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.
Read the detailed description
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.
The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- Pre-hospital cooling
- Keywords
- Therapeutic Hypothermia, Cardiac arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-hospital coolingBehavioural
Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.
| Study group | Role | What they receive |
|---|---|---|
| Pre-hospital cooling | Active comparator | Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs, initiation of an intravenous infusion of cold saline, and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia. Receives: Behavioral: Pre-hospital cooling |
| Usual pre-hospital care | No intervention | Patients in this arm will receive usual post-resuscitation care by paramedics. Usual post-resuscitation care does not include initiation of cooling in the pre-hospital setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of in-hospital cooling
The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
Measured: within 6 hours of emergency department arrival
Secondary outcomes (7)
Mortality at hospital discharge
Proportion of deaths at hospital discharge
Measured: Hospital discharge
Mortality during transport
Proportion of patients that die after randomization and during transport to hospital.
Measured: During transport to hospital
Mortality during 6 hours
Proportion of patients that die within 6 hours of emergency department arrival
Measured: Within 6 hours of emergency department arrival
Cooling ever in hospital
Proportion of patients for whom in-hospital therapeutic hypothermia is initiated or continued within 24 hours of emergency department arrival
Measured: within 24 hours of emergency department arrival
Median Modified Rankin score at hospital discharge
The median modified Rankin score at hospital discharge
Measured: hospital discharge
Good neurological outcome
The proportion of patients with Modified Rankin Scale = 0, 1, or 2 at hospital discharge.
Measured: hospital discharge
Time of transport to hospital
Mean time (minutes) from arrival of paramedics on the scene to arrival and transport of patient to emergency department.
Measured: During transport to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damon Scales, MD, Principal investigator, Sunnybrook HospitalLaurie Morrison, M.D., Study chair, Unity Health TorontoSteven Brooks, M.D., Study chair, Clinical ScientistRick Verbeek, MD, Study chair, Sunnybrook Centre for Prehospital MedicineSheldon Cheskes, MD, Study chair, Sunnybrook Centre for Prehospital Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528475
- Sponsor's protocol ID
- ICE PACS
- Status last verified
- Dec 2016
- First submitted
- 31 Oct 2011
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial
- ClinicalTrials.gov ID
- NCT01528475
- Acronym / sponsor ID
- ICE PACS
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- Therapeutic Hypothermia, Cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.
Detailed description
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.
The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital cooling | Active comparator | Behavioral: Pre-hospital coolingPatients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs, initiation of an intravenous infusion of cold saline, and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia. |
| Usual pre-hospital care | No intervention | –Patients in this arm will receive usual post-resuscitation care by paramedics. Usual post-resuscitation care does not include initiation of cooling in the pre-hospital setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
- Age equal to or greater than 18 years
- Defibrillation and/or chest compressions by EMS providers (including fire fighters)
- Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
- Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
Key exclusion criteria (8 listed)
- Trauma (including burns) associated with cardiac arrest
- Sepsis or serious infection suspected as cause of cardiac arrest
- Clinical evidence of active severe bleeding
- Suspected hypothermic cardiac arrest
- Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-hospital coolingPatients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia. | Behavioural | Pre-hospital cooling |
Primary outcome
Success of in-hospital cooling
Time frame: within 6 hours of emergency department arrival
The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
7 secondary outcomes
Mortality at hospital discharge
Time frame: Hospital discharge
Mortality during transport
Time frame: During transport to hospital
Mortality during 6 hours
Time frame: Within 6 hours of emergency department arrival
Cooling ever in hospital
Time frame: within 24 hours of emergency department arrival
Median Modified Rankin score at hospital discharge
Time frame: hospital discharge
Good neurological outcome
Time frame: hospital discharge
Time of transport to hospital
Time frame: During transport to hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon Scales, MD principal investigator
Sunnybrook Hospital
Laurie Morrison, M.D. study chair
Unity Health Toronto
Steven Brooks, M.D. study chair
Clinical Scientist
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-hospital cooling in people with Out of Hospital Cardiac Arrest, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of in-hospital cooling (time frame: within 6 hours of emergency department arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.