Trial Outcomes & Findings for Pre-ROSC Intra-Nasal Cooling Effectiveness (NCT NCT00808236)

NCT ID: NCT00808236

Last Updated: 2011-06-10

Results Overview

ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 1-hour after arrest
• Results posted on: 2011-06-10

Participant Flow

Patients were recruited by emergency medical system advanced life support personnel over an 8-month period (November 2008 through June 2009). Patients appearing to meet the study criteria were randomized during ongoing resuscitation procedures. Patients that survived to hospital admission were followed until death or hospital discharge.

Due to the emergency nature of the research, patients were often randomized into the study before all exclusion criteria could be ruled out (e.g., "Do Not Attempt to Resuscitate" (DNAR) orders, drug over-dose (OD), cerebrovascular accident (CVA)). Therefore, patients meeting pre-defined exclusion criteria were not included in the outcome measures.

Participant milestones

Measure	RhinoChill Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Overall Study STARTED	96	104
Overall Study Met Eligibility Criteria	84	101
Overall Study Included in Analysis	83	99
Overall Study Achieved ROSC	33	43
Overall Study Admitted to Hospital	30	42
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	82	91

Reasons for withdrawal

Measure	RhinoChill Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Overall Study Was not resuscitated	50	56
Overall Study Pre-defined exclusion	13	3
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	0	1
Overall Study Death	18	30

Baseline Characteristics

Pre-ROSC Intra-Nasal Cooling Effectiveness

Baseline characteristics by cohort

Measure	RhinoChill n=96 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=104 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.	Total n=200 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Age Categorical Between 18 and 65 years	35 participants n=93 Participants	44 participants n=4 Participants	79 participants n=27 Participants
Age Categorical >=65 years	47 participants n=93 Participants	55 participants n=4 Participants	102 participants n=27 Participants
Age Continuous	66.4 years STANDARD_DEVIATION 13.2 • n=93 Participants	64.8 years STANDARD_DEVIATION 13.5 • n=4 Participants	65 years STANDARD_DEVIATION 14 • n=27 Participants
Gender Female	23 participants n=93 Participants	22 participants n=4 Participants	45 participants n=27 Participants
Gender Male	59 participants n=93 Participants	77 participants n=4 Participants	136 participants n=27 Participants
Region of Enrollment Czech Republic	2 participants n=93 Participants	4 participants n=4 Participants	6 participants n=27 Participants
Region of Enrollment Belgium	46 participants n=93 Participants	51 participants n=4 Participants	97 participants n=27 Participants
Region of Enrollment Germany	32 participants n=93 Participants	33 participants n=4 Participants	65 participants n=27 Participants
Region of Enrollment Italy	3 participants n=93 Participants	6 participants n=4 Participants	9 participants n=27 Participants
Region of Enrollment Sweden	13 participants n=93 Participants	10 participants n=4 Participants	23 participants n=27 Participants
Bystander CPR Received bystander CPR	31 participants n=93 Participants	45 participants n=4 Participants	76 participants n=27 Participants
Bystander CPR Did not receive bystander CPR	51 participants n=93 Participants	54 participants n=4 Participants	105 participants n=27 Participants
Evaluable Participants Did not meet all Inclusion/Exclusion Criteria	13 participants n=93 Participants	3 participants n=4 Participants	16 participants n=27 Participants
Evaluable Participants No data obtained	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Evaluable Participants Total evaluable	82 participants n=93 Participants	99 participants n=4 Participants	181 participants n=27 Participants
First Rhythm VF/VT	24 participants n=93 Participants	32 participants n=4 Participants	56 participants n=27 Participants
First Rhythm Asystole	40 participants n=93 Participants	44 participants n=4 Participants	84 participants n=27 Participants
First Rhythm PEA/EMD	18 participants n=93 Participants	23 participants n=4 Participants	41 participants n=27 Participants
Elapsed time from collapse until: EMS CPR Initiated	8 minutes n=93 Participants	8 minutes n=4 Participants	8 minutes n=27 Participants
Elapsed time from collapse until: First Defibrillation Shock (VF only)	12 minutes n=93 Participants	12 minutes n=4 Participants	12 minutes n=27 Participants
Elapsed time from collapse until: Advanced Life Support (ALS) Arrived	12 minutes n=93 Participants	11 minutes n=4 Participants	12 minutes n=27 Participants
Elapsed time from collapse until: Intravenous (IV) Access Acquired	16 minutes n=93 Participants	15 minutes n=4 Participants	16 minutes n=27 Participants
Elapsed time from collapse until: Airway Protected	18 minutes n=93 Participants	16 minutes n=4 Participants	17 minutes n=27 Participants
Elapsed time from collapse until: Randomized	20 minutes n=93 Participants	18 minutes n=4 Participants	19 minutes n=27 Participants
Elapsed time from collapse until: Cooling Initiated	23 minutes n=93 Participants	113 minutes n=4 Participants	30 minutes n=27 Participants
Elapsed time from collapse until: ROSC Achieved	32 minutes n=93 Participants	30 minutes n=4 Participants	31 minutes n=27 Participants
Elapsed time from collapse until: Arrived at Hospital	59 minutes n=93 Participants	60 minutes n=4 Participants	60 minutes n=27 Participants

PRIMARY outcome

Timeframe: 1-hour after arrest

Population: Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients.

ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.

Outcome measures

Measure	RhinoChill n=83 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=99 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Achieve Return of Spontaneous Circulation (ROSC)	33 participants	43 participants

PRIMARY outcome

Timeframe: 30 days after arrest

Population: The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be "DNAR" upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82.

The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.

Outcome measures

Measure	RhinoChill n=82 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=99 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Survived to Hospital Discharge	14 participants	13 participants

PRIMARY outcome

Timeframe: 30-days after arrest

Population: The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn.

The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact."

1. - Good cerebral performance: little to no deficit.

2. - Moderate cerebral disability: capable of independent activities of daily life

3. - Severe cerebral disability: conscious, but dependent on others for daily support

4. - Coma or vegetative state

5. - Death or brain death

Outcome measures

Measure	RhinoChill n=82 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=99 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Survived Neurologically-Intact	11 participants	9 participants

SECONDARY outcome

Timeframe: hospital discharge

Population: Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel

ROSC, survival, and neurologically-intact survival

Outcome measures

Measure	RhinoChill n=24 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=32 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Primary Outcomes in Sub-group With VF/VT as First Rhythm Achieved ROSC	17 participants	21 participants
Primary Outcomes in Sub-group With VF/VT as First Rhythm Survived to Hospital Discharge	10 participants	10 participants
Primary Outcomes in Sub-group With VF/VT as First Rhythm Survived Neurologically-Intact	8 participants	6 participants

SECONDARY outcome

Timeframe: within 8 hours after enrollment

Population: The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures.

The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.

Outcome measures

Measure	RhinoChill n=24 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=32 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Time to Therapeutic Temperature Time to 34C Tympanic Temperature	102 minutes Interval 81.0 to 155.0	291 minutes Interval 183.0 to 416.0
Time to Therapeutic Temperature Time to 34C Core Temperature	155 minutes Interval 124.0 to 315.0	284 minutes Interval 172.0 to 471.0
Time to Therapeutic Temperature Time to 33C Tympanic Temperature	170 minutes Interval 101.0 to 335.0	377 minutes Interval 258.0 to 635.0
Time to Therapeutic Temperature Time to 33C Core Temperature	315 minutes Interval 180.0 to 477.0	389 minutes Interval 280.0 to 649.0

SECONDARY outcome

Timeframe: Hospital Discharge

Population: Evaluable patients admitted to the hospital

Length of stay data for patients admitted to the hospital will be calculated for:

1. Days on ventilator

2. Days in intensive care without ventilator

3. Days in general ward

Outcome measures

Measure	RhinoChill n=30 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=42 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Length of Stay Non-survivors	3.0 days Interval 2.3 to 5.4	2.6 days Interval 0.3 to 5.1
Length of Stay Survivors - ventilator days	4.2 days Interval 3.0 to 5.8	8.8 days Interval 5.2 to 11.0
Length of Stay Survivors - ICU days (no ventilator)	2.0 days Interval 0.6 to 6.5	3.0 days Interval 2.0 to 5.0
Length of Stay Survivors - general ward days	12.8 days Interval 7.0 to 20.0	11.5 days Interval 7.0 to 16.0

SECONDARY outcome

Timeframe: 7 days after arrest

Population: All enrolled patients; see additional modified "at risk" population based on study attrition in the Adverse Event section.

These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.

Outcome measures

Measure	RhinoChill n=96 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=104 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Serious Adverse Events (SAEs)	6 all participants	12 all participants

SECONDARY outcome

Timeframe: 24 hours after arrest

Population: all enrolled participants

These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.

Outcome measures

Measure	RhinoChill n=96 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=104 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
24-hour Adverse Events (AE) RhinoChill-related	17 all participants	0 all participants
24-hour Adverse Events (AE) Other	0 all participants	3 all participants

POST_HOC outcome

Timeframe: Hospital discharge

Population: Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients)

ROSC, Survival, and neurologically-intact survival

Outcome measures

Measure	RhinoChill n=63 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=74 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse Achieved ROSC	26 participants	35 participants
Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse Survived to Hospital Discharge	13 participants	10 participants
Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse Survived Neurologically-Intact	10 participants	6 participants

POST_HOC outcome

Timeframe: Hospital discharge

Population: Subset of patients that achieved ROSC and were subsequently admitted to the hospital.

Suvival and neurologically intact survival

Outcome measures

Measure	RhinoChill n=30 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=42 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Outcomes for Patients Admitted to the Hospital Survived to Hospital Discharge	14 participants	13 participants
Outcomes for Patients Admitted to the Hospital Survived Neurologically-Intact	11 participants	9 participants

POST_HOC outcome

Timeframe: Hospital discharge

Population: Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital

Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital

Outcome measures

Measure	RhinoChill n=16 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=21 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Outcomes for VF Patients Admitted to the Hospital All Survivors	10 participants	10 participants
Outcomes for VF Patients Admitted to the Hospital Neurologically-Intact Survivors	8 participants	6 participants

POST_HOC outcome

Timeframe: Hospital Discharge

Population: Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital.

Outcome measures

Measure	RhinoChill n=22 Participants Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=34 Participants Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital Survived to Hospital Discharge	13 participants	10 participants
Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital Survived Neurologically-Intact	10 participants	6 participants

Adverse Events

RhinoChill

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Control

Serious events: 12 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	RhinoChill n=96 participants at risk Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=104 participants at risk Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Cardiac disorders Acute Myocardial Infarct	7.4% 2/27 • Number of events 2 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	3.1% 1/32 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Blood and lymphatic system disorders Bleeding	1.0% 1/96 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	0.96% 1/104 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Nervous system disorders Convulsions	1.0% 1/96 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	0.96% 1/104 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Cardiac disorders Lethal/long-lasting arrhythmia	3.7% 1/27 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	6.2% 2/32 • Number of events 2 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
General disorders Metabolic acidosis	0.00% 0/27 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	6.2% 2/32 • Number of events 2 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Renal and urinary disorders Renal Failure	3.7% 1/27 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	6.2% 2/32 • Number of events 2 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
General disorders Sepsis/Multi-organ failure	0.00% 0/27 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	9.4% 3/32 • Number of events 3 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.

Other adverse events

Measure	RhinoChill n=96 participants at risk Intra-arrest cooling with the RhinoChill during advanced cardiac life support	Control n=104 participants at risk Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
Cardiac disorders Arrhythmia	0.00% 0/27 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	3.1% 1/32 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Blood and lymphatic system disorders Bleeding	3.1% 3/96 • Number of events 3 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	1.9% 2/104 • Number of events 2 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Skin and subcutaneous tissue disorders Nasal discoloration	13.5% 13/96 • Number of events 13 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	0.00% 0/104 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
Skin and subcutaneous tissue disorders Peri-orbital emphysema	1.0% 1/96 • Number of events 1 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.	0.00% 0/104 • Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours. Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.

Additional Information

Becky Inderbitzen, Vice President of Clincial Affairs

BeneChill, Inc.

Phone: 858-695-8118

Email: binderbitzen@benechill.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60