RecruitingNot ApplicableNCT07204223

Tulip Airway in Difficult Mask Ventilation (TADMV)

Comparison of the Tulip Airway and the Guedel Airway in Anticipated Difficult Mask Ventilation: A Prospective, Randomized, Controlled Crossover Trial


Sponsor

Ayse Zeynep Turan Civraz

Enrollment

30 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

  • 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 Criteria8

  • 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

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Interventions

DEVICETulip Airway

In this study, patients scheduled for surgery under general anesthesia who meet the criteria for anticipated difficult mask ventilation will be included. Randomization will be performed to determine which device will be used first. If the Tulip airway is selected as the first device in the randomization process, mask ventilation will be initiated with the Tulip airway.

DEVICEGuedel Airway

In this study, patients scheduled for surgery under general anesthesia who meet the criteria for anticipated difficult mask ventilation will be included. Randomization will be performed to determine which device will be used first. If the Guedel airway is selected as the first device in the randomization process, mask ventilation will be initiated with the Guedel airway.


Locations(1)

Kocaeli City Hospital

İzmit, Kocaeli, Turkey (Türkiye)

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NCT07204223