Tulip versus Guedel mouth airways for people with difficult mask ventilation
Official title: Comparison of the Tulip Airway and the Guedel Airway in Anticipated Difficult Mask Ventilation: A Prospective, Randomized, Controlled Crossover Trial
Run by Kocaeli City Hospital · NCT07204223 · Data updated 2026-11-12
We will test whether the Tulip airway or the standard Guedel airway makes mask ventilation easier for adults having elective surgery who are at higher risk of difficult mask ventilation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Kocaeli City Hospital Government |
| Locations | 1 site (İzmit, Kocaeli) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07204223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 scheduled for elective surgery under general anesthesia with at least two risk factors for difficult mask ventilation (for example age >55, beard, edentulism, BMI ≥30, history of OSAS/snoring, neck circumference >43 cm, or retrognathia) and ASA physical status 1–3 who can provide informed consent are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have prior airway surgery or major craniofacial anomalies, severe cardiopulmonary disease, or who require emergency or specialized airway management are excluded and unlikely to benefit from this device comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Bag-mask ventilation after anesthesia induction can be challenging in patients with certain risk factors, and oral airway devices are commonly used to help maintain ventilation. This interventional comparison enrolls adults undergoing elective surgery who have at least two predictors of difficult mask ventilation and applies either a Tulip airway or a Guedel airway during bag-mask ventilation. Clinicians will record measures of ventilation effectiveness, ease of use, and any ventilation-related complications during the induction period. The goal is to determine which device better facilitates safe and effective mask ventilation in this higher-risk population.
Why it matters
Potential benefit: If successful, the Tulip airway could make bag-mask ventilation more reliable and reduce the need for urgent advanced airway maneuvers in patients at risk for difficult mask ventilation.
How similar studies have gone: The Tulip airway is a relatively new device and direct, high-quality comparative evidence versus the long-established Guedel airway is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Kocaeli City Hospital
İzmit, Kocaeli, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Ayşe Z Turan Cıvraz, Assoc. Prof. — Kocaeli City Hospital
- Study coordinator: Ayşe Z Turan Cıvraz, Assoc. Prof.
- Email: ayse.zeynep@gmail.com
- Phone: +905054695850
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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New-generation GMA versus conventional inflatable laryngeal mask for airway management during general anesthesia
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Validate the MASCAN score for predicting difficult facemask ventilation
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.