Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04215302

Enrollment

Registered

2020-01-02

Start date

2019-09-17

Completion date

2019-11-05

Last updated

2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anaesthesia

Brief summary

the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer

Detailed description

sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.

Interventions

DEVICElaryngeal mask

the size of laryngeal mask given to the patient was based on patient's weight measurement

Study design

Observational model

CASE_CROSSOVER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 10 Years

Healthy volunteers

Inclusion criteria

* aged 1 -10 years old * Malay race * scheduled for general anesthesia procedure with laryngeal mask

Exclusion criteria

\- disagree to be included in the study

Design outcomes

Primary

Measure	Time frame	Description
successful insertion of laryngeal mask	3 minutes	observe the sign of successful insertion of laryngeal mask

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026