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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
Sponsor:
Collaborators:
Changi General Hospital
KK Women's and Children's Hospital
Ng Teng Fong General Hospital
Tan Tock Seng Hospital
National University Hospital, Singapore
Khoo Teck Puat Hospital
Singapore Civil Defence Force
Information provided by (Responsible Party):
Singapore General Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: Laryngeal Mask Airway (LMA) Device: Laryngeal Tube (LT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 965 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. successful intubation (number [ Time Frame: 1 year ]
    Confirm clinically by auscultation and equal chest rise on bagging


Secondary Outcome Measures :
  1. number of placement attempts required [ Time Frame: 10 minutes ]
  2. Dislodgement rates [ Time Frame: 1 hour ]
  3. Time to successful placement of airway device [ Time Frame: 10 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Singapore
Singapore Civil Defence Force
Singapore, Singapore, 408827
Sponsors and Collaborators
Singapore General Hospital
Changi General Hospital
KK Women's and Children's Hospital
Ng Teng Fong General Hospital
Tan Tock Seng Hospital
National University Hospital, Singapore
Khoo Teck Puat Hospital
Singapore Civil Defence Force
Investigators
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Principal Investigator: Jing Jing Chan, MBBS Singapore General Hospital
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02607644    
Other Study ID Numbers: 2015/2181
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Singapore General Hospital:
Intubation
Ventilation
Cardiac arrest
prehospital
Laryngeal Masks
Laryngeal Tube
airway management
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases