Effects of Video LMA Cuff Pressure in Tympanoplasty.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSamsun University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who refuse to participate in the study
Illiterate patients
Patients unsuitable for laryngeal mask airway ventilation
Patients with preoperative sore throat
Trial population
Adult patients scheduled to undergo elective tympanoplasty surgery under general anesthesia requiring supraglottic airway management with a Video LMA.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
48 Participants
are grouped into 2 trial groupsGroup A: Video LMA Cuff Pressure <= 50 cm H2O
Group B: Video LMA Cuff Pressure > 50 cm H2O
Trial outcomes
Primary outcomes
1
Oropharyngeal Leak Pressure
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.
Time frame
IntraoperativelySecondary outcomes
1
Postoperative Sore Throat
The incidence and severity of postoperative sore throat reported by patients. Assessed using a standard 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe
Time frame
Up to 24 hours postoperatively2
Postoperative Dysphagia and Hoarseness
The presence and incidence of swallowing difficulty (dysphagia) and voice alteration (hoarseness) reported by patients.
Time frame
Up to 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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