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

NCT ID: NCT01718795

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Cardiac Arrest During and/or Resulting From A Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bag-valve mask ventilation

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

Group Type: ACTIVE_COMPARATOR

Bag-valve mask or laryngeal tube ventilation

Intervention Type: DEVICE

Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR

Laryngeal Tube

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

Group Type: ACTIVE_COMPARATOR

Bag-valve mask or laryngeal tube ventilation

Intervention Type: DEVICE

Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR

Interventions

Bag-valve mask or laryngeal tube ventilation

Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR

Intervention Type: DEVICE

Other Intervention Names

BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Baubin, MD

OTHER

Sponsor Role: lead

Responsible Party

Michael Baubin, MD

Prof. MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Baubin, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 29073915 (View on PubMed)

Related Links

http://www2.i-med.ac.at/anaesthesie/

Departement of Anesthesiology and Critical Care Medicine Innsbruck, where study investigators belong to

Other Identifiers

Prehospital LTS vs. BVM

Identifier Type: -

Identifier Source: org_study_id