Laryngeal Tube vs Laryngeal Mask Airway

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.

Conditions

• Cardiac Arrest

Interventions

DEVICE

Laryngeal Mask Airway (LMA)

Laryngeal Mask Airway (LMA) for Control group

DEVICE

Laryngeal Tube (LT)

Laryngeal Tube (LT) for Intervention group

Sponsors & Collaborators

• Changi General Hospital

  collaborator OTHER

• KK Women's and Children's Hospital

  collaborator OTHER_GOV

• Ng Teng Fong General Hospital

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Khoo Teck Puat Hospital

  collaborator OTHER

• Singapore Civil Defence Force

  collaborator OTHER

• Singapore General Hospital

  lead OTHER

Principal Investigators

• Jing Jing Chan, MBBS · Singapore General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-01-31

Completion

2018-05-31

Countries

• Singapore

Study Locations