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Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot & Feasibility Study (CAVE-I trial)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic Mechanical Ventilation | Experimental | Automatic Mechanical Ventilation during ACLS |
|
| Manual Ventilation | Active Comparator | Standard care with manual ventilation, Ambu-bagging, during ACLS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic Mechanical Ventilation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ROSC: return of spontaneous circulation | Rate of any ROSC after ACLS | Within 20 minutes of ACLS |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak pressure (only in automatic mechanical ventilation group) | Peak pressure of ventilator during the entire ACLS | Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center | Seoul | Korea (the Republic Of) | 07061 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38373673 | Derived | Shin J, Lee HJ, Jin KN, Shin JH, You KM, Lee SGW, Jung JH, Song KJ, Pak J, Park TY, Park CJ, Bae GT. Automatic Mechanical Ventilation vs Manual Bag Ventilation During CPR: A Pilot Randomized Controlled Trial. Chest. 2024 Aug;166(2):311-320. doi: 10.1016/j.chest.2024.02.020. Epub 2024 Feb 18. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
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It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
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|
| Manual Ventilation | Device | Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel |
|
Tidal volume (TV) and Minute volume (MV) during the entire ACLS
| During the entire ACLS time after randomization and endotracheal intubation |
| D012140 |
| Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |