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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04229862
Enrollment
110
Registered
2020-01-18
Start date
2020-02-14
Completion date
2020-05-05
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Masks, Urinary Bladder Neoplasms

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.

Interventions

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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First attempt success rateImmediately after mask airway insertionThe rate of success at the first attempt of laryngeal mask airway insertion

Secondary

MeasureTime frameDescription
Laryngeal mask airway insertion-related patient satisfactionAt postoperative 6 hoursA seven-point Likert scale
Second attempt success rateImmediately after mask airway insertionThe rate of success at the second attempt of laryngeal mask airway insertion
Third attempt success rateImmediately after mask airway insertionThe rate of success at the third attempt of laryngeal mask airway insertion
The percentage of glottic opening scoreImmediately after mask airway insertionThe percentage of glottic opening by fiberoptic view
Reposition rateAfter mask airway insertion (up to end of surgery)The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks
Complications associated with laryngeal mask airway insertionUp to postoperative 3 daysComplications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm
Oropharyngeal leak pressureImmediately after mask airway insertionOropharyngeal 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026