Clinical trial NCT01718795: Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR
Official title: Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiac Arrest During and/or Resulting From A Procedure
Keywords: Airway
Cardiac Arrest
CPR
Ventilation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Cardiac arrest

Exclusion Criteria:

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

Primary outcomes:
measure: Efficient ventilation
timeFrame: 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 outcomes:
measure: Aspiration
timeFrame: 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
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Michael Baubin, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.