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NCT04215302 Clinical Trial

Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

General Anaesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04215302
Other study ID # IndonesiaUAnes053
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 17, 2019
Est. completion date November 5, 2019

Study information
Verified date December 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date November 5, 2019
Est. primary completion date November 5, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Indonesia Indonesia University Jakarta DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (7)

Brain AI, Howard D. Lingual nerve injury associated with laryngeal mask use. Anaesthesia. 1998 Jul;53(7):713-4. — View Citation

King C, Street MK. Twelfth cranial nerve paralysis following use of a laryngeal mask airway. Anaesthesia. 1994 Sep;49(9):786-7. — View 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. Review. — View Citation

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. Review. — View 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. — View 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. — View Citation

Wynn JM, Jones KL. Tongue cyanosis after laryngeal mask airway insertion. Anesthesiology. 1994 Jun;80(6):1403. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary successful insertion of laryngeal mask observe the sign of successful insertion of laryngeal mask 3 minutes
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