Cardiac Arrest and Ventilation Method

Study Overview
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Brief Summary
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Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot & Feasibility Study (CAVE-I trial)

Detailed Description
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This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.

Official Title
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Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study

Conditions
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Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation

Intervention / Treatment
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* Device: Automatic Mechanical Ventilation
* Device: Manual Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital cardiac arrest (OHCA) Transferred by only EMS without prehospital return of spontaneous circulation (ROSC) ACLS for at least 20 minutes in the emergency room Arterial blood gas analysis at least once during ACLS Exclusion Criteria: In-hospital cardiac arrest (IHCA) Not transferred by Emergency Medical Service ROSC gained before arriving at the ER OHCA caused by trauma ACLS is not performed for more than 20 minutes because the death is obvious Not able to intubate the trachea

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic Mechanical Ventilation<br>Automatic Mechanical Ventilation during ACLS | Device: Automatic Mechanical Ventilation<br>* Ventilation settings: Mode: (S)Continuous Mandatory Ventilation Rate: 10 b/min. Tidal Volume: 500 ml (male), 450 ml (female) I:E=1:1 Positive end expiratory pressure (PEEP): 5 cmH2O Flow trigger: off Oxygen: 100% Alarms: Pressure 70 cmH20, Tidal volume 100   1,000 ml<br>|
| Active Comparator: Manual Ventilation<br>Standard care with manual ventilation, Ambu-bagging, during ACLS | Device: Manual Ventilation<br>* Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC: return of spontaneous circulation | Rate of any ROSC after ACLS | Within 20 minutes of ACLS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gas analysis (ABGA) parameters | PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L | The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test. | 
| Ventilation parameters | Tidal volume (TV) and Minute volume (MV) during the entire ACLS | During the entire ACLS time after randomization and endotracheal intubation |