Tulip Airway in Difficult Mask Ventilation (TADMV)
Turkey (Türkiye)30 participantsStarted 2025-10-01
Plain-language summary
During surgery, right after anesthesia is given, the first step to help the patient breathe is to provide breathing support with a mask. This step is very important because if there is a problem with mask ventilation, the anesthesia team must quickly use other methods to help the patient breathe.
For some people, mask ventilation can be more difficult. Factors such as older age, having a beard, missing teeth, being overweight, sleep apnea, or certain facial shapes can make this process harder.
To make mask ventilation easier, special devices placed in the mouth are used. The most common one is called the Guedel airway. In recent years, a new device called the Tulip airway has also been introduced. The shape and features of the Tulip airway are designed to make breathing support easier.
In this study, we will compare the Tulip airway and the Guedel airway in patients who are expected to have more difficult mask ventilation. Our goal is to find out which device makes it easier and safer to help patients breathe.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 18 and 75 years
* Patients scheduled for elective surgery under general anesthesia
* Patients with at least two risk factors for difficult mask ventilation, including:
* Age over 55 years
* Presence of beard
* Edentulism (missing teeth)
* Obesity (Body Mass Index (BMI) ≥ 30 kg/m²)
* History of obstructive sleep apnea syndrome (OSAS) or snoring
* Neck circumference \> 43 cm
* Retrognathia (small jaw structure)
* Patients classified as American Society of Anesthesiologist (ASA) physical status 1, 2, or 3
* Patients who provide informed consent
Exclusion Criteria:
* Pregnant or breastfeeding women
* Patients with a history of airway surgery (e.g., tracheostomy, maxillofacial surgery)
* Patients with severe cardiopulmonary diseases (e.g., advanced Chronic obstructive Pulmonary Disease (COPD), pulmonary hypertension, severe heart failure)
* Patients with craniofacial anomalies or significant anatomical airway deformities
* Patients requiring emergency surgery
* Patients with gastroesophageal reflux disease (GERD) and high risk of aspiration
* Patients with active upper respiratory tract infection
* Patients with a history of difficult intubation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.