A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue… (NCT05987293) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
China94 participantsStarted 2023-10-19
Plain-language summary
Article Summary
1. Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia.
2. There is a lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
3. This is a protocol of a single-center, prospective, paralled-group clinical trial based on the measurement of dynamic changes in pressure between the tracheal tube and the tongue in different position during the surgery.
4. The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include the time to first successful recovery of oral intake of fluids and solid food and airway-related events.
5. This trial aims to find the best indicators for tracheal tracheal tube-related tongue injury and to provide solid basis for optimizing airway protection strategies and surgical positioning.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. ASA I-III
✓. Age 18-85 years old
✓. Scheduled for elective surgery with tracheal intubation under general anesthesia, with operation duration ≥2 hours
✓. The intended surgical position will be supine, prone, cervical traction or beach chair position
✓. Obtained informed consent
Exclusion criteria
✕. Informed consent is not obtained
✕. Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway
✕. History of head and neck radiotherapy
✕. Deformity, trauma, infection and active bleeding exist in the mouth and tongue
✕. Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive pulmonary disease, laryngeal osteomalacia
What they're measuring
1
tracheal tube-related tongue injury
Timeframe: Starting from the time after surgery till post-operative day 7 (POD7)