Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

Completed

• Conditions: General Anaesthesia
• Interventions: Device: laryngeal mask

• Registration Number: NCT04215302
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2019-09-17
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-05
• Status Verified: 2019-12
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laryngeal mask size	laryngeal mask	laryngeal mask size determines according to weight measurement

Primary Outcome Measures

Name	Time	Method
successful insertion of laryngeal mask	3 minutes	observe the sign of successful insertion of laryngeal mask

Trial Locations

Locations (1)

Indonesia University; 🇮🇩 Jakarta, DKI Jakarta, Indonesia