Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

NCT ID: NCT04215302

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-17

Study Completion Date

2019-11-05

Brief Summary

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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

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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.

Conditions

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General Anaesthesia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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laryngeal mask size

laryngeal mask size determines according to weight measurement

laryngeal mask

Intervention Type DEVICE

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

Interventions

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laryngeal mask

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Kapuangan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Kapuangan, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Indonesia University

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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Michalek P, Donaldson W, Vobrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Biomed Res Int. 2015;2015:746560. doi: 10.1155/2015/746560. Epub 2015 Dec 13.

Reference Type RESULT
PMID: 26783527 (View on PubMed)

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.

Reference Type RESULT
PMID: 25254120 (View on PubMed)

Brain AI, Howard D. Lingual nerve injury associated with laryngeal mask use. Anaesthesia. 1998 Jul;53(7):713-4. doi: 10.1046/j.1365-2044.1998.537d-az0584d.x. No abstract available.

Reference Type RESULT
PMID: 9771185 (View on PubMed)

King C, Street MK. Twelfth cranial nerve paralysis following use of a laryngeal mask airway. Anaesthesia. 1994 Sep;49(9):786-7. doi: 10.1111/j.1365-2044.1994.tb04452.x. No abstract available.

Reference Type RESULT
PMID: 7978135 (View on PubMed)

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.

Reference Type RESULT
PMID: 10212721 (View on PubMed)

Wynn JM, Jones KL. Tongue cyanosis after laryngeal mask airway insertion. Anesthesiology. 1994 Jun;80(6):1403. No abstract available.

Reference Type RESULT
PMID: 8010489 (View on PubMed)

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.

Reference Type RESULT
PMID: 23130725 (View on PubMed)

Other Identifiers

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IndonesiaUAnes053

Identifier Type: -

Identifier Source: org_study_id

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