Oropharyngeal Leak PressureNCT07849322

Effects of Video LMA Cuff Pressure in Tympanoplasty.

An observational study of Oropharyngeal Leak Pressure and Airway Management, run by Samsun University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Oropharyngeal Leak Pressure, Airway Management, Postoperative Sore Throat, Cough, Hoarseness
How many people: 48 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 25 Sep 2026to 1 Feb 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

R.Burak Ferli, MD contact

+90 542 645 92 95

rburakferli.md@gmail.com

Turkey (Türkiye)1 site

Samsun City Hospital
Samsun, 55080
R.Burak Ferli, MD, +90 542 645 92 95, rburakferli.md@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Video LMA Cuff Pressure on Oropharyngeal Leak Pressure in Tympanoplasty

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
Medical subject headings: Cough, Hoarseness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07849322
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Intraoperatively

Secondary outcomes (2)

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
Measured: Up to 24 hours postoperatively
Postoperative Dysphagia and Hoarseness
The presence and incidence of swallowing difficulty (dysphagia) and voice alteration (hoarseness) reported by patients.
Measured: Up to 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 20261 Feb 2027

First posted30 Sep 2026
Study start25 Sep 2026 (estimated)
Primary completion1 Jan 2027 (estimated)
Study completion1 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Oropharyngeal Leak PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07849322
Sponsor's protocol ID: GOKAEK 2026/7/32
Status last verified: Sep 2026
First submitted: 24 Sep 2026
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36308748
Ramachandran SK, Kumar AM. Supraglottic airway devices. Respir Care. 2014 Jun;59(6):920-31; discussion 931-2. doi: 10.4187/respcare.02976.
PubMed 24891199
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

Interested in taking part?

R.Burak Ferli, MD

+90 542 645 92 95

rburakferli.md@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Effects of Continuous Monitoring and Progressive Regulation of Inflatable Laryngeal Mask Airway Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Elderly Patients
Elderly (People Aged 65 or More), LMA

All Oropharyngeal Leak Pressure trials