Effects of Video LMA Cuff Pressure in Tympanoplasty.

NCT07849322 | Not Yet Recruiting

• 1 other identifier: GOKAEK 2026/7/32
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Leak Pressure; Airway Management; Postoperative Sore Throat, Cough, Hoarseness

Keywords

Cuff Pressure; Video Laryngeal Mask Airway; Oropharyngeal Leak Pressure

Outcome Measures

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.

  Intraoperatively

Secondary Outcomes (2)

• Postoperative Sore Throat

  Up to 24 hours postoperatively

• Postoperative Dysphagia and Hoarseness

  Up to 24 hours postoperatively

Study Arms (2)

Video LMA Cuff Pressure <= 50 cm H2O

Patients undergoing tympanoplasty under general anesthesia in whom the Video LMA cuff pressure is measured at 50 cm H2O or lower. Oropharyngeal leak pressure is measured intraoperatively after visual confirmation of device position, and postoperative pharyngeal symptoms are monitored for the first 24 hours.

Video LMA Cuff Pressure > 50 cm H2O

Patients undergoing tympanoplasty under general anesthesia in whom the Video LMA cuff pressure is measured higher than 50 cm H2O. Oropharyngeal leak pressure is measured intraoperatively after visual confirmation of device position, and postoperative pharyngeal symptoms are monitored for the first 24 hours.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled to undergo elective tympanoplasty surgery under general anesthesia requiring supraglottic airway management with a Video LMA.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun City Hospital

Samsun, 55080, Turkey (Türkiye)

Location

Related Publications (3)

• Gomez-Rios MA, Lopez T, Sastre JA, Gaszynski T, Van Zundert AAJ. Video laryngeal masks in airway management. Expert Rev Med Devices. 2022 Nov;19(11):847-858. doi: 10.1080/17434440.2022.2142558. Epub 2022 Nov 8.

  PMID: 36308748 BACKGROUND

• Ramachandran SK, Kumar AM. Supraglottic airway devices. Respir Care. 2014 Jun;59(6):920-31; discussion 931-2. doi: 10.4187/respcare.02976.

  PMID: 24891199 BACKGROUND

• 1) Machado, H. (2016). Supraglottic Airway Devices: A Review in a New Era of Airway Management. Journal of Anesthesia Clinical Research. https://doi.org/10.4172/2155-6148.1000647

  BACKGROUND

MeSH Terms

Conditions

Cough; Hoarseness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

R.Burak Ferli, MD

CONTACT

+90 542 645 92 95; rburakferli.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)