Status:

RECRUITING

Tulip Airway in Difficult Mask Ventilation (TADMV)

Lead Sponsor:

Ayse Zeynep Turan Civraz

Conditions:

Difficult Mask Ventilation

Airway Devices

Eligibility:

All Genders

18-75 years

Phase:

NA

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 ...

Detailed Description

The first step in airway management following anesthesia induction is the period of bag-mask ventilation. This step is the most critical phase of airway management because, if mask ventilation fails, ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07204223

Start Date

October 1 2025

End Date

December 31 2025

Last Update

November 18 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kocaeli City Hospital

İzmit, Kocaeli, Turkey (Türkiye), 41060