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

Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR- A Prospective, Controlled, Randomised, Multi-center Trial

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01718795
Enrollment
78
Registered
2012-10-31
Start date
2012-09-30
Completion date
2015-09-30
Last updated
2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest During and/or Resulting From A Procedure

Keywords

Airway, Cardiac Arrest, CPR, Ventilation

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.

Interventions

DEVICEBag-valve mask or laryngeal tube ventilation

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

Sponsors

Michael Baubin, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cardiac arrest

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Efficient ventilationFrom 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

MeasureTime frameDescription
AspirationFrom 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 2014Aspiration will be assessed 24hrs after CPR with bronchoscopy

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026