Clinical trial NCT04215302: Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient
Official title: Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anaesthesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric population aged 1 - 10 years old underwent general anesthesia procedure with laryngeal mask airway device

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.

Eligibility criteria: 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

Primary outcomes:
measure: successful insertion of laryngeal mask
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Indonesia University
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Christopher Kapuangan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.
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citation: Lowinger D, Benjamin B, Gadd L. Recurrent laryngeal nerve injury caused by a laryngeal mask airway. Anaesth Intensive Care. 1999 Apr;27(2):202-5. doi: 10.1177/0310057X9902700214.
citation: Wynn JM, Jones KL. Tongue cyanosis after laryngeal mask airway insertion. Anesthesiology. 1994 Jun;80(6):1403. No abstract available.
citation: van Zundert TC, Brimacombe JR, Ferson DZ, Bacon DR, Wilkinson DJ. Archie Brain: celebrating 30 years of development in laryngeal mask airways. Anaesthesia. 2012 Dec;67(12):1375-85. doi: 10.1111/anae.12003.x.