Clinical trial NCT05987293: A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Official title: Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tracheal Tube-related Tongue Injury
Keywords: intubation
general anesthesia
endotracheal intubation
post extubation dysphagia
post extubation stridor
tongue edema
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied in China-Japan Friendship Hospital will be enrolled (See in Sample Size calculation). Patients will be divided into two groups according to the surgery: supine position (Supine group) and the high-risk positions (Flexion group) which include the prone position, cervical traction position, and beach chair position. Patients with existing oral or airway problems, or other factors influence postoperative recovery of diet will be excluded.

Brief 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.

Detailed description: Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, leading to severe throat pain, dysphagia, and respiratory function impairment. There is a lack of indicators and clinical awareness of this issue. Therefore we have designed this study to accurately monitor the tracheal tube-tongue pressure in different surgical position during general anesthesia.

Method This is a prospective, single-center observational study. Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied will be enrolled. Patients will be divided into supine position (Supine group) and the high-risk positions (Flexion group) groups. Dynamic changes in pressure between the tracheal tube and the tongue are measured. All patients will be followed up until 7 days after operation. 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.

Discussion The study aims to explore the risk factors and pressure thresholds for tracheal tracheal tube-related tongue injury.

Eligibility criteria: Inclusion Criteria:

1. ASA I-III
2. Age 18-85 years old
3. Scheduled for elective surgery with tracheal intubation under general anesthesia, with operation duration ≥2 hours
4. The intended surgical position will be supine, prone, cervical traction or beach chair position
5. Obtained informed consent

Exclusion Criteria:

1. Informed consent is not obtained
2. Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway
3. History of head and neck radiotherapy
4. Deformity, trauma, infection and active bleeding exist in the mouth and tongue
5. Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive pulmonary disease, laryngeal osteomalacia
6. Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction
7. Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia, severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac stenosis and other basic diseases
8. Postoperative total parenteral nutrition therapy is planned

Primary outcomes:
measure: tracheal tube-related tongue injury
timeFrame: Starting from the time after surgery till post-operative day 7 (POD7)
Secondary outcomes:
measure: time of first smooth water intake
timeFrame: Starting from the time after surgery till post-operative day 7 (POD7)
measure: time of first smooth solid food intake
timeFrame: Starting from the time after surgery till post-operative day 7 (POD7)
measure: airway related events
timeFrame: Starting from the time after surgery till post-operative day 7 (POD7)
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Wei Xia Li, MD
role: STUDY_DIRECTOR
References: