Laryngeal Tube vs Laryngeal Mask Airway
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|ClinicalTrials.gov Identifier: NCT02607644|
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : June 6, 2018
Introduction: The laryngeal mask airway (LMA) is used as the primary airway by paramedics in Singapore Civil Defense Force's Emergency Ambulance Service (SCDF's EAS) in the management of out-of-hospital cardiac arrest, because endotracheal intubation requires skilled and experienced personnel, and local paramedics are not trained to this level of skill and competency. However, self-reported insertion success rates by paramedics in the field are currently only about 50-87%. Devices like the laryngeal tube have been shown to have higher placement success rates and fewer complications.
Aim: Investigators aim to evaluate the efficacy and safety of a new device, the Laryngeal Tube (LT), compared to the LMA. They hypothesize that the LT is superior to the LMA in terms of placement success rates by paramedics in SCDF's EAS, and is associated with fewer adverse events.
Methodology: Investigators propose to conduct a prospective, longitudinal multi-centre randomized trial comparing LMA and LT in patients with cardiac arrest (medical or traumatic) managed by SCDF EAS. The trial will recruit 1,015 eligible patients presenting to SCDF irrespective of destination hospital over a period of 1 year to detect an expected 15% difference in placement success rate. Currently the LMA is used as standard of care by SCDF's EAS in patients with cardiac arrest.
Results: Besides the primary outcome, the secondary outcomes of dislodgment rates, time to placement, number of attempts and adverse events will be analyzed and will be useful in guiding future SCDF cardiac arrest protocols.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Device: Laryngeal Mask Airway (LMA) Device: Laryngeal Tube (LT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||965 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Evaluation of Laryngeal Tube and Laryngeal Mask Airway for Cardiac Arrest Treatment in Emergency Ambulances in Singapore|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||May 2018|
Experimental: Laryngeal Tube (LT)
VBM Laryngeal Tube (Intervention)
Device: Laryngeal Tube (LT)
Laryngeal Tube (LT) for Intervention group
Active Comparator: Laryngeal Mask Airway (LMA)
Laryngeal Mask Airway (LMA)
Device: Laryngeal Mask Airway (LMA)
Laryngeal Mask Airway (LMA) for Control group
- successful intubation (number [ Time Frame: 1 year ]Confirm clinically by auscultation and equal chest rise on bagging
- number of placement attempts required [ Time Frame: 10 minutes ]
- Dislodgement rates [ Time Frame: 1 hour ]
- Time to successful placement of airway device [ Time Frame: 10 minutes ]
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): NCT02607644
|Singapore Civil Defence Force|
|Singapore, Singapore, 408827|
|Principal Investigator:||Jing Jing Chan, MBBS||Singapore General Hospital|