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

Michael Baubin, MD

Status and phase: Terminated; Phase 4

Conditions: Cardiac Arrest During and/or Resulting From A Procedure

Treatments: Device: Bag-valve mask or laryngeal tube ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01718795

Prehospital LTS vs. BVM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiac arrest

Exclusion criteria

• Paramedic does not want to use laryngeal tube
• Physician on site before paramedic
• Foreign body airway obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 2 patient groups

Bag-valve mask ventilation

Active Comparator group

Description:

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

Treatment:

Device: Bag-valve mask or laryngeal tube ventilation

Laryngeal Tube

Active Comparator group

Description:

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

Treatment:

Device: Bag-valve mask or laryngeal tube ventilation