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

Primary Purpose

Cardiac Arrest During and/or Resulting From A Procedure

Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Bag-valve mask or laryngeal tube ventilation
Sponsored by
Michael Baubin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest During and/or Resulting From A Procedure focused on measuring Airway, Cardiac Arrest, CPR, Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bag-valve mask ventilation

Laryngeal Tube

Arm 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

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

Outcomes

Primary Outcome Measures

Efficient ventilation
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
Aspiration will be assessed 24hrs after CPR with bronchoscopy

Full Information

First Posted
June 7, 2012
Last Updated
March 23, 2016
Sponsor
Michael Baubin, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01718795
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruiting too slow, down to 1-0 patients per month
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Baubin, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest During and/or Resulting From A Procedure
Keywords
Airway, Cardiac Arrest, CPR, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bag-valve mask ventilation
Arm Type
Active Comparator
Arm 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
Arm Title
Laryngeal Tube
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Bag-valve mask or laryngeal tube ventilation
Other Intervention Name(s)
BVM(Ambu,Germany);LT(VBM Medizintechnik,Germany)ventilation
Intervention Description
Interventions are either "Bag-valve mask (BVM)" or "Laryngeal tube (LT)" ventilation during CPR
Primary Outcome Measure Information:
Title
Efficient ventilation
Description
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.
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)
Secondary Outcome Measure Information:
Title
Aspiration
Description
Aspiration will be assessed 24hrs after CPR with bronchoscopy
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Baubin, Prof. MD
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29073915
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.
Results Reference
derived
Links:
URL
http://www2.i-med.ac.at/anaesthesie/
Description
Departement of Anesthesiology and Critical Care Medicine Innsbruck, where study investigators belong to

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

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