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The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic ventilation | Experimental | After the advanced airway is placed, an automatic pneumatic ventilator will be connected and provides ventilation in every 6 seconds. |
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| Manual ventilation | Active Comparator | After the advanced airway is placed, a bag valve mask resuscitator will be connected and provides ventilation in every 6 seconds by the emergency medical technician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic ventilation | Device | The FDA-approved device used is "Meditech" MICROVENT RESUSCITATOR, which is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. It is powered by the airflow from the oxygen tank and provides ventilation in fixed interval. It has a pressure valve which will release the pressure once the airway pressure exceeds its threshold. In the current study, the threshold is set at 60 mmH2O. The tidal volume is set at 500-600 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of any return of spontaneous circulation (ROSC) | The patient achieved ROSC in prehospital or inhospital resuscitation. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of sustained ROSC in 24 hours | The patient survives for 24 hours after arriving the hospital. | up to 24 hours |
| The percentage of survival to hospital discharge | The patient survives to discharge from the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation rate in the prehospital resuscitation | The ventilation rate recorded by the portable monitor with feedback sensor (BVM help). | up to 1 hour |
| Tidal volume in the prehospital resuscitation | The tidal volume recorded by the portable monitor with feedback sensor (BVM help). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Yi Fan, M.D. | Contact | +886972654382 | chengyi.md@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Edward Pei-Chuan Huang, M.D., M.S. | National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsinchu Branch | Recruiting | Hsinchu | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39624188 | Derived | Fan CY, Huang SS, Chen CH, Sung CW, Chang CH, Hung TH, Liu YC, Huang EP. Prehospital ventilation strategies in out-of-hospital cardiac arrest: A protocol for a randomized controlled trial (PIVOT trial). Resusc Plus. 2024 Nov 16;20:100827. doi: 10.1016/j.resplu.2024.100827. eCollection 2024 Dec. |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Only the emergency medical service crew will know the intervention in each participant. The patient will not be aware of the type of ventilation strategy because of OHCA status. The investigator and outcomes assessor will not able to acquire the allocation results until the study ends.
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| Manual ventilation | Device | The adult size bag-valve mask is connected to the endotracheal tube, supraglottic airway or tracheostomy tube. The interval, pressure and volume of the ventilation is controlled by the emergency medical technicians. |
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| up to 90 days |
| The percentage of favorable neurological outcome after discharge | The patient survives to discharge from the hospital with Cerebral Performance Categories Scale 1 or 2. | up to 90 days |
| Chest compression fraction | The chest compression fraction during prehospital resuscitation recorded by the monitor. | up to 1 hour |
| The percentage of intravenous catheter placement | Whether the patient has an IV catheter placed in the prehospital setting. | up to 1 hour |
| The percentage of epinephrine injection | Whether the patient has epinephrine injected in the prehospital setting. | up to 1 hour |
| The satisfaction of emergency medical technician (EMT) during the dispatch | The outcome contained five questions:
The EMTs answer in the 5-level scale (highly disagree, disagree, neutral, agree, highly agree) | up to 5 hours |
| The percentage of pneumothorax | Unilateral, bilateral or tension pneumothorax which might be associated with the ventilation strategy. | up to 3 days |
| up to 1 hour |
| Chest compression depth in the prehospital resuscitation | The chest compression depth recorded by the portable monitor with feedback pad. | up to 1 hour |
| Chest compression rate in the prehospital resuscitation | The chest compression rate recorded by the portable monitor with feedback pad. | up to 1 hour |
| End-tidal carbon dioxide level (ETCO2) | The ETCO2 recorded in the prehospital resuscitation process. | 1 hour |