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A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg

NCT02478983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-28

No results posted yet for this study

Summary

The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing \<10kg.

Conditions

  • Laryngeal Mask Airway

Interventions

DEVICE

LMA Supreme

The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.

DEVICE

LMA Proseal

The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Sook Hui Chaw, M.Med · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478983 on ClinicalTrials.gov