Tracheal Tube-related Tongue InjuryNCT05987293
A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
An observational study of Tracheal Tube-related Tongue Injury, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Tube-related Tongue Injury
- What is being tested?
- 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.
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
- Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction
- Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia, severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac stenosis and other basic diseases
- Postoperative total parenteral nutrition therapy is planned
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Article Summary
- Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia.
- There is a lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Tracheal Tube-related Tongue Injury
- Being tested
- 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.
- Keywords
- intubation, general anesthesia, endotracheal intubation, post extubation dysphagia, post extubation stridor, tongue edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Device
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
tracheal tube-related tongue injury
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.
Measured: Starting from the time after surgery till post-operative day 7 (POD7)
Secondary outcomes (3)
time of first smooth water intake
time of first smooth water intake
Measured: Starting from the time after surgery till post-operative day 7 (POD7)
time of first smooth solid food intake
time of first smooth solid food intake
Measured: Starting from the time after surgery till post-operative day 7 (POD7)
airway related events
bronchospasm, aspiration, secondary intubation, respiratory tract infection, respiratory insufficiency, prolonged oxygen therapy, etc.
Measured: Starting from the time after surgery till post-operative day 7 (POD7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Oct 2023
- Primary completion20 Aug 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tracheal Tube-related Tongue InjuryStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Fang Wang, China-Japan Friendship Hospital
- Investigators
- Wei Xia Li, MD, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987293
- Sponsor's protocol ID
- ChinaJapanFHAnesth
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Wang LF, Liang N, Zheng MT, Ma HN, Huang JS, Fan GH, Zhao J, Li WX. Exploration of tracheal tube contact pressure and simplified risk indicators for postoperative laryngopharyngeal discomfort: a prospective pilot study. Anaesthesiol Intensive Ther. 2026 Jun 19;58(1):127-136. doi: 10.5114/ait/221781.
PubMed 42417175Wang LF, Zheng MT, Liang N, Ma HN, Li WX. Study of postoperative laryngopharyngeal discomfort: protocol for a single-centre cohort study. BMJ Open. 2024 Jan 2;14(1):e079841. doi: 10.1136/bmjopen-2023-079841.
PubMed 38167285
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
- ClinicalTrials.gov ID
- NCT05987293
- Acronym / sponsor ID
- ChinaJapanFHAnesth
- Conditions
- Tracheal Tube-related Tongue Injury
- Keywords
- intubation, general anesthesia, endotracheal intubation, post extubation dysphagia, post extubation stridor, tongue edema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Article Summary
- Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia.
- There is a lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | – | 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.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) |
| Flexion group | – | 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.The high-risk positions (Flexion group) which include patients scheduled for surgery under the prone position, cervical traction position, and beach chair position. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Flexion group, Supine group |
Primary outcome
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.
3 secondary outcomes
time of first smooth water intake
Time frame: Starting from the time after surgery till post-operative day 7 (POD7)
time of first smooth solid food intake
Time frame: Starting from the time after surgery till post-operative day 7 (POD7)
airway related events
Time frame: Starting from the time after surgery till post-operative day 7 (POD7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 42417175Wang LF, Liang N, Zheng MT, Ma HN, Huang JS, Fan GH, Zhao J, Li WX. Exploration of tracheal tube contact pressure and simplified risk indicators for postoperative laryngopharyngeal discomfort: a prospective pilot study. Anaesthesiol Intensive Ther. 2026 Jun 19;58(1):127-136. doi: 10.5114/ait/221781.
- Derived from this study: PubMed 38167285Wang LF, Zheng MT, Liang N, Ma HN, Li WX. Study of postoperative laryngopharyngeal discomfort: protocol for a single-centre cohort study. BMJ Open. 2024 Jan 2;14(1):e079841. doi: 10.1136/bmjopen-2023-079841.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia Li, MD study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Tube-related Tongue Injury, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tracheal tube-related tongue injury (time frame: Starting from the time after surgery till post-operative day 7 (POD7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987293, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.