Effects of Video LMA Cuff Pressure in Tympanoplasty.

NCT07849322 · tracked via the Priya Life Science Turkey tracker

Sponsor

Samsun University

Phase

Observational

Started

2026-09-25

Last updated

2026-09-30

Condition(s) studied

Oropharyngeal Leak PressureAirway ManagementPostoperative Sore Throat, Cough, Hoarseness

Study summary

This prospective observational study aims to evaluate the effects of different cuff pressure levels of the Video Laryngeal Mask Airway (Video LMA) on airway safety, ventilation efficacy, and postoperative pharyngeal symptoms in patients undergoing tympanoplasty surgery. Patients are evaluated in two groups based on the measured Video LMA cuff pressure: 50 cm H2O or lower, and higher than 50 cm H2O. The primary outcome is oropharyngeal leak pressure (OLP). Secondary outcomes include the incidence and severity of postoperative pharyngeal symptoms, such as sore throat, dysphagia, and hoarseness, assessed during the first 24 hours postoperatively. Video LMA provides visual confirmation of correct anatomical position, allowing the effects of cuff pressure to be evaluated independently of device malposition.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Scheduled for elective tympanoplasty under general anesthesia * American Society of Anesthesiologists (ASA) physical status I-II-III * Aged between 18 and 75 years * Written informed consent obtained prior to surgery Exclusion Criteria: * Patients who refuse to participate in the study * Illiterate patients * Patients unsuitable for laryngeal mask airway ventilation * Patients with preoperative sore throat * Patients who used NSAIDs within 24 hours prior to surgery * Patients diagnosed with gastroesophageal reflux * Patients with a history of oropharyngeal and/or head and neck surgery * Patients with ASA physical status IV * Patients with cognitive impairment or unable to cooperate * Patients diagnosed with psychiatric disorders (schizophrenia, mania, depression, etc.) * Patients using antipsychotic medication for longer than 4 weeks

Primary outcome measure(s)

Oropharyngeal Leak Pressure — Intraoperatively
Oropharyngeal leak pressure (OLP) is measured in cm H2O after confirming proper Video LMA placement. With a fresh gas flow set at 6-8 L/min, the expiratory (APL) valve is gradually closed, and OLP is recorded as the airway pressure at which an audible air leak is detected.

Trial sites (1)

Facility	City	Region	Status
Samsun City Hospital	Samsun	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07849322 on ClinicalTrials.gov ↗ ← All trials in Turkey