Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

NCT04215302 | Completed DMC

• 1 other identifier: IndonesiaUAnes053
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

General Anaesthesia

Outcome Measures

Primary Outcomes (1)

• successful insertion of laryngeal mask

  observe the sign of successful insertion of laryngeal mask

  3 minutes

Study Arms (1)

laryngeal mask size

laryngeal mask size determines according to weight measurement

Device: laryngeal mask

Interventions

laryngeal mask DEVICE

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

laryngeal mask size

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric population aged 1 - 10 years old underwent general anesthesia procedure with laryngeal mask airway device

You may qualify if:

• aged 1 -10 years old
• Malay race
• scheduled for general anesthesia procedure with laryngeal mask

You may not qualify if:

• \- disagree to be included in the study

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Indonesia University

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (7)

• 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.

  PMID: 26783527 RESULT

• 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.

  PMID: 25254120 RESULT

• 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.

  PMID: 9771185 RESULT

• 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.

  PMID: 7978135 RESULT

• 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.

  PMID: 10212721 RESULT

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

  PMID: 8010489 RESULT

• 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.

  PMID: 23130725 RESULT

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Christopher Kapuangan, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: September 17, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)