Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07204223

Tulip Airway in Difficult Mask Ventilation (TADMV)

Led by Ayse Zeynep Turan Civraz · Updated on 2025-11-18

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tulip Airway in Difficult Mask Ventilation (TADMV)

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 75 years
  • Scheduled for elective surgery under general anesthesia
  • Have at least two risk factors for difficult mask ventilation, including age over 55 years, beard, missing teeth, obesity (BMI 2 30 kg/m), history of obstructive sleep apnea or snoring, neck circumference over 43 cm, or small jaw (retrognathia)
  • Classified as American Society of Anesthesiologist physical status 1, 2, or 3
  • Provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of airway surgery such as tracheostomy or maxillofacial surgery
  • Severe cardiopulmonary diseases like advanced COPD, pulmonary hypertension, or severe heart failure
  • Craniofacial anomalies or significant airway deformities
  • Require emergency surgery
  • Gastroesophageal reflux disease with high risk of aspiration
  • Active upper respiratory tract infection
  • History of difficult intubation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kocaeli City Hospital

İzmit, Kocaeli, Turkey (Türkiye), 41060

Actively Recruiting

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Research Team

A

Ayşe Z Turan Cıvraz, Assoc. Prof.

CONTACT

B

Bedirhan Günel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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