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Effect of Head Elevation on LMA Insertion

Primary Purpose

Laryngeal Masks, Urinary Bladder Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laryngeal mask airway insertion
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Laryngeal Masks

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evaluation with 14 cm high pillow

Evaluation with 7 cm high pillow

Arm Description

When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow.

When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow.

Outcomes

Primary Outcome Measures

First attempt success rate
The rate of success at the first attempt of laryngeal mask airway insertion

Secondary Outcome Measures

The percentage of glottic opening score
The percentage of glottic opening by fiberoptic view
Laryngeal mask airway insertion-related patient satisfaction
A seven-point Likert scale
Second attempt success rate
The rate of success at the second attempt of laryngeal mask airway insertion
Third attempt success rate
The rate of success at the third attempt of laryngeal 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.
Reposition rate
The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks
Complications associated with laryngeal mask airway insertion
Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm

Full Information

First Posted
January 13, 2020
Last Updated
May 27, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04229862
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Masks, Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation with 14 cm high pillow
Arm Type
Experimental
Arm Description
When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow.
Arm Title
Evaluation with 7 cm high pillow
Arm Type
Active Comparator
Arm Description
When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow.
Intervention Type
Procedure
Intervention Name(s)
Laryngeal mask airway insertion
Intervention Description
Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection
Primary Outcome Measure Information:
Title
First attempt success rate
Description
The rate of success at the first attempt of laryngeal mask airway insertion
Time Frame
Immediately after mask airway insertion
Secondary Outcome Measure Information:
Title
The percentage of glottic opening score
Description
The percentage of glottic opening by fiberoptic view
Time Frame
Immediately after mask airway insertion
Title
Laryngeal mask airway insertion-related patient satisfaction
Description
A seven-point Likert scale
Time Frame
At postoperative 6 hours
Title
Second attempt success rate
Description
The rate of success at the second attempt of laryngeal mask airway insertion
Time Frame
Immediately after mask airway insertion
Title
Third attempt success rate
Description
The rate of success at the third attempt of laryngeal mask airway insertion
Time Frame
Immediately after mask airway insertion
Title
Oropharyngeal leak pressure
Description
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.
Time Frame
Immediately after mask airway insertion
Title
Reposition rate
Description
The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks
Time Frame
After mask airway insertion (up to end of surgery)
Title
Complications associated with laryngeal mask airway insertion
Description
Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm
Time Frame
Up to postoperative 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30104838
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.
Results Reference
background
PubMed Identifier
26401265
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.
Results Reference
background
PubMed Identifier
2917111
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.
Results Reference
background
PubMed Identifier
17272252
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.
Results Reference
background
PubMed Identifier
21602973
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.
Results Reference
background
PubMed Identifier
33174199
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.
Results Reference
derived

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Effect of Head Elevation on LMA Insertion

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