NCT02607644

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
965

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

November 4, 2015

Last Update Submit

June 3, 2018

Conditions

Cardiac Arrest

Keywords

IntubationVentilationCardiac arrestprehospitalLaryngeal MasksLaryngeal Tubeairway management

Outcome Measures

Primary Outcomes (1)

  • successful intubation (number

    Confirm clinically by auscultation and equal chest rise on bagging

    1 year

Secondary Outcomes (3)

  • number of placement attempts required

    10 minutes

  • Dislodgement rates

    1 hour

  • Time to successful placement of airway device

    10 minutes

Study Arms (2)

Laryngeal Tube (LT)

EXPERIMENTAL

VBM Laryngeal Tube (Intervention)

Device: Laryngeal Tube (LT)

Laryngeal Mask Airway (LMA)

ACTIVE COMPARATOR

Laryngeal Mask Airway (LMA)

Device: Laryngeal Mask Airway (LMA)

Interventions

Laryngeal Mask Airway (LMA)DEVICE

Laryngeal Mask Airway (LMA) for Control group

Laryngeal Mask Airway (LMA)
Laryngeal Tube (LT)DEVICE

Laryngeal Tube (LT) for Intervention group

Laryngeal Tube (LT)

Eligibility Criteria

Age13 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 13-100 years old
  • Cardiac arrest (medical or traumatic)
  • Adjunct airway device is needed

You may not qualify if:

  • Resuscitation is not indicated (e.g. decapitation, rigor mortis, dependant lividity)
  • Pregnant women
  • Conscious, intact gag reflex
  • Known ingestion of caustic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Civil Defence Force

Singapore, 408827, Singapore

Location

MeSH Terms

Conditions

Heart ArrestRespiratory Aspiration

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jing Jing Chan, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 18, 2015

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

May 1, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

SG(1)