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Completed

NCT Number: NCT04215302

Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

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

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Key information

Conditions

General Anaesthesia

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indonesia University

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal Mask

Device

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

Primary outcomes

  1. successful insertion of laryngeal mask

    Time frame: 3 minutes

    observe the sign of successful insertion of laryngeal mask

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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