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Recruiting too slow, down to 1-0 patients per month
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During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.
During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. This study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR. This study may provide information if paramedics in an emergency should ventilate as they do traditionally with bag-valve mask ventilation or if they should ventilate with a laryngeal tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bag-valve mask ventilation | Active Comparator | Bag-valve mask ventilation during CPR, i.e. traditional ventilation during CPR. Airway management with bag-valve mask ventilation and efficient ventilation: yes or no? Intervention is "Bag-valve mask ventilation" during CPR |
|
| Laryngeal Tube | Active Comparator | Laryngeal Tube Ventilation during CPR, i.e. the alternative ventilation technique to be compared to the traditional technique. Airway management with laryngeal tube and efficient ventilation: yes or no? Intervention is "Ventilation through laryngeal tube" during CPR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bag-valve mask or laryngeal tube ventilation | Device | Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficient ventilation | Does chest rise clearly during CPR? Thus efficient ventilation will be assessed during CPR, which may last on average between 20 and 60min. Therefore efficient ventilation will be assessed from starting CPR at 0min to 20min or rarely 60min or longer. | From start of paramedic ventilating the patient during CPR until emergency physician takes over ventilation or patient breathes again spontaneously after return of spontaneous circulation (ROSC) |
| Measure | Description | Time Frame |
|---|---|---|
| Aspiration | Aspiration will be assessed 24hrs after CPR with bronchoscopy | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month after enrollment of the last patient at August 30th 2014 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Baubin, Prof. MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29073915 | Derived | Fiala A, Lederer W, Neumayr A, Egger T, Neururer S, Toferer E, Baubin M, Paal P. EMT-led laryngeal tube vs. face-mask ventilation during cardiopulmonary resuscitation - a multicenter prospective randomized trial. Scand J Trauma Resusc Emerg Med. 2017 Oct 26;25(1):104. doi: 10.1186/s13049-017-0446-1. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |