Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04215302
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 41

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
General Anaesthesia	Device: laryngeal mask

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 Design

• Study Type: Observational
• Actual Enrollment: 66 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement
• Actual Study Start Date: Sep 17, 2019
• Actual Primary Completion Date: Nov 5, 2019
• Actual Study Completion Date: Nov 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
laryngeal mask size laryngeal mask size determines according to weight measurement	Device: laryngeal mask; the size of laryngeal mask given to the patient was based on patient's weight measurement

Outcome Measures

Primary Outcome Measures

1. successful insertion of laryngeal mask [3 minutes]

   observe the sign of successful insertion of laryngeal mask

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indonesia University	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Christopher Kapuangan, MD, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Kapuangan, MD, Indonesia University
• ClinicalTrials.gov Identifier: NCT04215302
• Other Study ID Numbers: IndonesiaUAnes053
• First Posted: Jan 2, 2020
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 2, 2020