Clinical trial NCT04229862: Effect of Head Elevation on LMA Insertion
Official title: Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Urinary Bladder Neoplasms
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.

Detailed description: The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled transurethral bladder tumor resection under general anesthesia
* 20-79 years of age
* American Society of Anesthesiologists physical status ≤3
* Patients who are voluntarily agreed to this clinical study

Exclusion Criteria:

* History of difficult airway
* Expected difficult airway by physical examination
* Unstable teeth or teeth loss
* Obesity (body mass index ≥ 30)
* Recent history of upper respiratory infection
* Patients who are not fasted or who are at risk of aspiration

Primary outcomes:
measure: First attempt success rate
timeFrame: Immediately after mask airway insertion
Secondary outcomes:
measure: The percentage of glottic opening score
timeFrame: Immediately after mask airway insertion
measure: Laryngeal mask airway insertion-related patient satisfaction
timeFrame: At postoperative 6 hours
measure: Second attempt success rate
timeFrame: Immediately after mask airway insertion
measure: Third attempt success rate
timeFrame: Immediately after mask airway insertion
measure: Oropharyngeal leak pressure
timeFrame: Immediately after mask airway insertion
measure: Reposition rate
timeFrame: After mask airway insertion (up to end of surgery)
measure: Complications associated with laryngeal mask airway insertion
timeFrame: Up to postoperative 3 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohta M. Head elevation beyond sniffing position - An aid to airway management. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):247-248. doi: 10.4103/joacp.JOACP_173_17. No abstract available.
citation: Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
citation: Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
citation: Takenaka I, Aoyama K, Iwagaki T, Ishimura H, Kadoya T. The sniffing position provides greater occipito-atlanto-axial angulation than simple head extension: a radiological study. Can J Anaesth. 2007 Feb;54(2):129-33. doi: 10.1007/BF03022009.
citation: Jun JH, Baik HJ, Kim JH, Kim YJ, Chang RN. Comparison of the ease of laryngeal mask airway ProSeal insertion and the fiberoptic scoring according to the head position and the presence of a difficult airway. Korean J Anesthesiol. 2011 Apr;60(4):244-9. doi: 10.4097/kjae.2011.60.4.244. Epub 2011 Apr 26.
citation: Park JY, Yu J, Hong JH, Hwang JH, Kim YK. Head elevation and laryngeal mask airway Supreme insertion: A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Mar;65(3):343-350. doi: 10.1111/aas.13742. Epub 2020 Nov 28.