Effect of Head Elevation on LMA Insertion

Urinary Bladder Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229862
• Other study ID #: 2020-0020
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: May 5, 2020

Study information

• Verified date: May 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Masks
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Laryngeal mask airway insertion
Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate	The rate of success at the first attempt of laryngeal mask airway insertion	Immediately after mask airway insertion
Secondary	The percentage of glottic opening score	The percentage of glottic opening by fiberoptic view	Immediately after mask airway insertion
Secondary	Laryngeal mask airway insertion-related patient satisfaction	A seven-point Likert scale	At postoperative 6 hours
Secondary	Second attempt success rate	The rate of success at the second attempt of laryngeal mask airway insertion	Immediately after mask airway insertion
Secondary	Third attempt success rate	The rate of success at the third attempt of laryngeal mask airway insertion	Immediately after mask airway insertion
Secondary	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
Secondary	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)
Secondary	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