Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial

Conditions
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Cardiac Arrest During and/or Resulting From A Procedure

Intervention / Treatment
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* Device: Bag-valve mask or laryngeal tube ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac arrest Exclusion Criteria: Paramedic does not want to use laryngeal tube Physician on site before paramedic Foreign body airway obstruction

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bag-valve mask ventilation<br>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 | Device: Bag-valve mask or laryngeal tube ventilation<br>* Interventions are either Bag-valve mask (BVM) or Laryngeal tube (LT) ventilation during CPR<br>* Other names: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation;|
| Active Comparator: Laryngeal Tube<br>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 | Device: Bag-valve mask or laryngeal tube ventilation<br>* Interventions are either Bag-valve mask (BVM) or Laryngeal tube (LT) ventilation during CPR<br>* Other names: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway, Cardiac Arrest, CPR, Ventilation