Tulip Airway in Difficult Mask Ventilation (TADMV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAyse Zeynep Turan Civraz
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Patients aged between 18 and 75 years
Patients scheduled for elective surgery under general anesthesia
Age over 55 years
Presence of beard
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Tulip Airway
DeviceIn 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.
Guedel Airway
DeviceIn 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Guedel GroupActive comparator 1 intervention
Group B: Tulip GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Expiratory Tidal Volume
Patients in Group G will have a Guedel airway placed in a size appropriate for their weight, and the practitioner will hold the mask with both hands. Patients in Group T will have a Tulip airway placed in a size appropriate for their weight. In both groups, to prevent variability on the part of the practitioner, patients will be ventilated in pressure-controlled mode at 15 (centimeters of water) cmH₂O pressure, respiratory rate 10 breaths/min, an I:E ratio of 1:3, and an oxygen flow rate of 10 L/min without Positive End Expiratory Pressure (PEEP). For both groups, successful mask ventilation will be defined as a tidal volume (TV) of at least 250 ml.
Time frame
Minute 5Sponsors and contacts
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Ayse Zeynep Turan Civraz
Lead sponsor
Kocaeli City Hospital
Sponsor institution
Source ClinicalTrials.gov