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

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ClinicalTrials.gov Identifier: NCT01718795
Recruitment Status : Terminated (Recruiting too slow, down to 1-0 patients per month)
First Posted : October 31, 2012
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Baubin, MD, Medical University Innsbruck

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
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?

Intervention is "Bag-valve mask ventilation" during CPR

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

Intervention is "Ventilation through laryngeal tube" during CPR

Device: Bag-valve mask or laryngeal tube ventilation
Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR
Other Name: BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation



Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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 ]
    Aspiration will be assessed 24hrs after CPR with bronchoscopy



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Michael Baubin, MD, Medical University Innsbruck:
Airway
Cardiac Arrest
CPR
Ventilation

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases