A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury

• ClinicalTrials.gov Identifier: NCT05987293
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: October 26, 2023
• Sponsor: China-Japan Friendship Hospital
• Information provided by (Responsible Party): Li Fang Wang, China-Japan Friendship Hospital

Tracking Information

• First Submitted Date: August 3, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: October 26, 2023
• Actual Study Start Date: October 19, 2023
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2023)

tracheal tube-related tongue injury [ Time Frame: Starting from the time after surgery till post-operative day 7 (POD7) ]

The primary composite endpoint is assessed as incidence of tracheal tube-related tongue injury, which is either the state of severe sore throat (VAS≥4), dysphagia after extubation, or any of the symptoms of macroglossia.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 3, 2023)

• time of first smooth water intake [ Time Frame: Starting from the time after surgery till post-operative day 7 (POD7) ]
  time of first smooth water intake
• time of first smooth solid food intake [ Time Frame: Starting from the time after surgery till post-operative day 7 (POD7) ]
  time of first smooth solid food intake
• airway related events [ Time Frame: Starting from the time after surgery till post-operative day 7 (POD7) ]
  bronchospasm, aspiration, secondary intubation, respiratory tract infection, respiratory insufficiency, prolonged oxygen therapy, etc.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Tracheal Tube-related Tongue Injury

Intervention

Device: Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.

A flexible film sensor with a thickness of 0.11mm is placed between the tongue and the tracheal tube to measure the distribution, join force and dynamic changes of pressure at different site of the tongue. Five channels of pressure values will be recorded separately: (Ch1) the tip of the tongue, (Ch2) the middle of the tongue, (Ch3) the base of the tongue, (Ch4) the right side at the base of the tongue, (Ch5) the left side at the base of the tongue. The pressure values at the following points during the operation will be recorded: (t1) after intubation, (t2) highest pressure during patient positioning, (t3) after position fixed, (t4) at the end of surgery, (t5) before extubation.

Study Groups/Cohorts

• Supine group
  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)
  Intervention: Device: Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.
• Flexion group
  The high-risk positions (Flexion group) which include patients scheduled for surgery under the prone position, cervical traction position, and beach chair position.
  Intervention: Device: Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2023): 54
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Li Fang WANG, MD; +8615011393879; lilythewolf@sina.com

Contact: Meng Tao ZHENG, MD; +8613671278389; dragon0303@sina.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05987293
• Other Study ID Numbers: ChinaJapanFHAnesth
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: The original data of this trial include Case Record Form (CRF) and electronic data capture (EDC). Informed consent forms with patients' signature will be stored in private database for clinical trial in the department of anesthesiology. Electronic information will be stored in authorized computer following clinical trial confidentiality. Patient records are available from GOODWILL Electronic Medical Record System (Version 6.0) with medical access only. Test data related to this trial will be uploaded to http://www.medresman.org.cn/ within 2 weeks after collection, available to be public.
• Access Criteria: http://www.medresman.org.cn/

• Current Responsible Party: Li Fang Wang, China-Japan Friendship Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: China-Japan Friendship Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Wei Xia Li, MD; China-Japan Friendship Hospital

• PRS Account: China-Japan Friendship Hospital
• Verification Date: October 2023