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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Michael Baubin, MD, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01718795
First received: June 7, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest During and/or Resulting From A Procedure
Device: Bag-valve mask or laryngeal tube ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Efficient ventilation [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Aspiration [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Aspiration will be assessed 24hrs after CPR with bronchoscopy


Enrollment: 78
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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?
Device: Bag-valve mask or laryngeal tube ventilation
Bag-valve mask (BVM) or laryngeal tube (LT) ventilation
Other Name: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation
Active Comparator: 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?
Device: Bag-valve mask or laryngeal tube ventilation
Bag-valve mask (BVM) or laryngeal tube (LT) ventilation
Other Name: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac arrest

Exclusion Criteria:

  • Paramedic does not want to use laryngeal tube
  • Physician on site before paramedic
  • Foreign body airway obstruction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718795

Locations
Austria
Medical University Innsbruck
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Michael Baubin, MD
Investigators
Principal Investigator: Michael Baubin, Prof. MD Medical University Innsbruck
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Baubin, MD, Prof. MD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01718795     History of Changes
Other Study ID Numbers: Prehospital LTS vs. BVM
Study First Received: June 7, 2012
Last Updated: May 9, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University Innsbruck:
Airway
Cardiac Arrest
CPR
Ventilation

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014