Effect of Head Elevation on LMA Insertion

Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Neoplasms; Laryngeal Masks
• Intervention / Treatment: Procedure: Laryngeal mask airway insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluation with 14 cm high pillow; When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow.	Procedure: Laryngeal mask airway insertion; Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection
Active Comparator: Evaluation with 7 cm high pillow; When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow.	Procedure: Laryngeal mask airway insertion; Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	The rate of success at the first attempt of laryngeal mask airway insertion	Immediately after mask airway insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of glottic opening score	The percentage of glottic opening by fiberoptic view	Immediately after mask airway insertion
Laryngeal mask airway insertion-related patient satisfaction	A seven-point Likert scale	At postoperative 6 hours
Second attempt success rate	The rate of success at the second attempt of laryngeal mask airway insertion	Immediately after mask airway insertion
Third attempt success rate	The rate of success at the third attempt of laryngeal mask airway insertion	Immediately after mask airway insertion
Oropharyngeal leak pressure	Oropharyngeal leak pressure is measured as follows: After setting the expiratory valve to 30 cmH2O at a fixed gas flow rate of 3 L/min, the maximum inflation pressure is measured when a noise of gas leakage is heard in the oropharynx via a stethoscope.	Immediately after mask airway insertion
Reposition rate	The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks	After mask airway insertion (up to end of surgery)
Complications associated with laryngeal mask airway insertion	Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm	Up to postoperative 3 days

Collaborators and Investigators

• Sponsor: Asan Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2020-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No