- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987293
A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
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.
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Li Fang Wang, MD
- Phone Number: +8615011393879
- Email: lilythewolf@sina.com
Study Contact Backup
- Name: Meng Tao ZHENG, MD
- Phone Number: +8613671278389
- Email: dragon0303@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- China-Japan Friendship Hospital
-
Contact:
- Li Fang Wang, MD
- Phone Number: +8615011393879
- Email: lilythewolf@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Starting from the time after surgery till post-operative day 7 (POD7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
time of first smooth solid food intake
|
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)
|
bronchospasm, aspiration, secondary intubation, respiratory tract infection, respiratory insufficiency, prolonged oxygen therapy, etc.
|
Starting from the time after surgery till post-operative day 7 (POD7)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wei Xia Li, MD, China-Japan Friendship Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChinaJapanFHAnesth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tracheal Tube-related Tongue Injury
-
University of ZurichCompletedElective Surgery Requiring Tracheal Intubation Using an Oral Tracheal TubeSwitzerland, Poland
-
Kyung Hee University Hospital at GangdongCompletedDepth of Tracheal TubeKorea, Republic of
-
Charite University, Berlin, GermanyCompleted
-
MAİDE YEŞİLYURTNecmettin Erbakan UniversityCompletedPressure Injury | Nasogastric Tube | Medical Device Site InjuryTurkey
-
Sichuan Cancer Hospital and Research InstituteSichuan Province, Department of Science and TechnologyNot yet recruitingLung Diseases | Lung Cancer | Tracheal Intubation Morbidity | Throat Injury | Bronchus; Injury
-
University Children's Hospital, ZurichCompletedNeed for Tracheal Tube Exchange | Presence of Post-extubation Laryngeal OedemaAustria, Belgium, Czech Republic, Germany, Slovakia, Sweden, Switzerland, United Kingdom
-
Selcuk UniversityCompletedEdema | Ischemia Reperfusion Injury | Side Effect | Tongue EnlargedTurkey
-
Al-Azhar UniversityUnknownRecurrent Hernia | Congenital Inguinal Hernia | Hernia Sac | Round Ligament; Injury | Fallopian Tube Injury | Ovarian InjuryEgypt
-
Ja Seong Bae, MD, phDKorea Health Industry Development InstituteActive, not recruitingThyroid CancerKorea, Republic of
-
Northwell HealthRecruitingEar Diseases | Middle Ear Disease | Pressure Injury | Eustachian Tube Dysfunction | Ear Barotrauma | Middle Ear; Injury | Middle Ear BarotraumaUnited States