Tulip Airway in Difficult Mask Ventilation (TADMV)

NCT07204223 | Recruiting

• 1 other identifier: KSH- AZTC- 02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Difficult Mask Ventilation; Airway Devices

Keywords

guedel airway; airway management; difficult bag mask ventilation; tulip airway

Outcome Measures

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.

  Minute 5

Study Arms (2)

Guedel Group

ACTIVE COMPARATOR

Guedel airway will be the first device during mask ventilation

Device: Guedel Airway

Tulip Group

EXPERIMENTAL

Tulip airway wil be the initial device for mask ventilation

Device: Tulip Airway

Interventions

Tulip Airway DEVICE

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.

Tulip Group

Guedel Airway DEVICE

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.

Guedel Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayse Zeynep Turan Civraz: lead

Study Sites (1)

Kocaeli City Hospital

İzmit, Kocaeli, 41060, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Shaikh A, Robinson PN, Hasan M. The Tulip GT(R) airway versus the facemask and Guedel airway: a randomised, controlled, cross-over study by Basic Life Support-trained airway providers in anaesthetised patients. Anaesthesia. 2016 Mar;71(3):315-9. doi: 10.1111/anae.13328. Epub 2015 Dec 19.

  PMID: 26684684 BACKGROUND

• Imashuku Y, Kitagawa H, Mizuno T. Usefulness of Tulip Airway in Edentulous Elderly Patients. Anesth Prog. 2022 Sep 1;69(3):9-12. doi: 10.2344/anpr-69-01-01.

  PMID: 36223186 BACKGROUND

• Koga K, Sata T, Kaku M, Takamoto K, Shigematsu A. Comparison of no airway device, the Guedel-type airway and the Cuffed Oropharyngeal Airway with mask ventilation during manual in-line stabilization. J Clin Anesth. 2001 Feb;13(1):6-10. doi: 10.1016/s0952-8180(00)00228-2.

  PMID: 11259887 BACKGROUND

• Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.

  PMID: 23364566 BACKGROUND

• Bradley P, Chapman G, Crooke B, Greenland K. Airway Assessment.

  BACKGROUND

• Bucher JT, Vashisht R, Cooper JS. Bag-Valve-Mask Ventilation. 2025 May 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441924/

  PMID: 28722953 BACKGROUND

Study Officials

• Ayşe Z Turan Cıvraz, Assoc. Prof.

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Z Turan Cıvraz, Assoc. Prof.

CONTACT

+905054695850; ayse.zeynep@gmail.com

Bedirhan Günel, MD

CONTACT

ayse.zeynep@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)