NCT04229862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

January 13, 2020

Last Update Submit

May 27, 2020

Conditions

Laryngeal MasksUrinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

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

    Immediately after mask airway insertion

Secondary Outcomes (7)

  • The percentage of glottic opening score

    Immediately after mask airway insertion

  • Laryngeal mask airway insertion-related patient satisfaction

    At postoperative 6 hours

  • Second attempt success rate

    Immediately after mask airway insertion

  • Third attempt success rate

    Immediately after mask airway insertion

  • Oropharyngeal leak pressure

    Immediately after mask airway insertion

  • +2 more secondary outcomes

Study Arms (2)

Evaluation with 14 cm high pillow

EXPERIMENTAL

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

Procedure: Laryngeal mask airway insertion

Evaluation with 7 cm high pillow

ACTIVE COMPARATOR

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

Procedure: Laryngeal mask airway insertion

Interventions

Laryngeal mask airway insertionPROCEDURE

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

Evaluation with 14 cm high pillowEvaluation with 7 cm high pillow

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (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.

    PMID: 30104838BACKGROUND

  • 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.

    PMID: 26401265BACKGROUND

  • 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.

    PMID: 2917111BACKGROUND

  • 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.

    PMID: 17272252BACKGROUND

  • 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.

    PMID: 21602973BACKGROUND

  • 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.

    PMID: 33174199DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Young-Kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

February 14, 2020

Primary Completion

April 5, 2020

Study Completion

May 5, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)