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A similar study was recently published with definitive results.
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The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.
Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6
The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.
This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induced Hypothermia | Experimental | Induced hypothermia after the return of spontaneous circulation by the application of ice packs to the axilla and groin with cold IV fluids |
|
| Regular Care | No Intervention | Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induced therapeutic hypothermia | Other | induced therapeutic hypothermia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Induced therapeutic hypothermia in the pre-hospital setting improves outcomes | Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge | followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated |
| Measure | Description | Time Frame |
|---|---|---|
| Regular treatment without induced therapeutic hypothermia | Patients will be treated under standing paramedic protocols without the induction of hypothermia. To determine if there is a difference in these outcomes in patients with prolonged transport to the hospital (> 20 minutes) versus those with shorter transport times. | followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Weichenthal, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Fresno | California | 93701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17767436 | Background | Finn JC, Bett JH, Shilton TR, Cunningham C, Thompson PL; National Heart Foundation of Australia Chest Pain Every Minute Counts Working Group. Patient delay in responding to symptoms of possible heart attack: can we reduce time to care? Med J Aust. 2007 Sep 3;187(5):293-8. doi: 10.5694/j.1326-5377.2007.tb01247.x. | |
| 17583414 | Background |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| D006324 | Heart Arrest, Induced |
| D000084102 | Return of Spontaneous Circulation |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| Fridman M, Barnes V, Whyman A, Currell A, Bernard S, Walker T, Smith KL. A model of survival following pre-hospital cardiac arrest based on the Victorian Ambulance Cardiac Arrest Register. Resuscitation. 2007 Nov;75(2):311-22. doi: 10.1016/j.resuscitation.2007.05.005. Epub 2007 Jun 20. |
| 16893352 | Background | Jennings PA, Cameron P, Walker T, Bernard S, Smith K. Out-of-hospital cardiac arrest in Victoria: rural and urban outcomes. Med J Aust. 2006 Aug 7;185(3):135-9. doi: 10.5694/j.1326-5377.2006.tb00498.x. |
| 10625721 | Background | Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86. |
| 11856794 | Background | Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289. |
| 1404770 | Background | Guidelines for cardiopulmonary resuscitation and emergency cardiac care. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Part IV. Special resuscitation situations. JAMA. 1992 Oct 28;268(16):2242-50. No abstract available. |
| 20359771 | Background | Hinchey PR, Myers JB, Lewis R, De Maio VJ, Reyer E, Licatese D, Zalkin J, Snyder G; Capital County Research Consortium. Improved out-of-hospital cardiac arrest survival after the sequential implementation of 2005 AHA guidelines for compressions, ventilations, and induced hypothermia: the Wake County experience. Ann Emerg Med. 2010 Oct;56(4):348-57. doi: 10.1016/j.annemergmed.2010.01.036. Epub 2010 Mar 31. |
| 20679551 | Background | Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2. |
| 20850254 | Background | Cabanas JG, Brice JH, De Maio VJ, Myers B, Hinchey PR. Field-induced therapeutic hypothermia for neuroprotection after out-of hospital cardiac arrest: a systematic review of the literature. J Emerg Med. 2011 Apr;40(4):400-9. doi: 10.1016/j.jemermed.2010.07.002. Epub 2010 Sep 17. |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |