Airway ManagementTRFINCT04343014
Tongue Root Retractor For Fibroscopic Intubation
A study testing Tongue Root Retractor and Conventional Fibroscope in people with Airway Management, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Tongue Root Retractor and Conventional Fibroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2016to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 70 years
- ASA graded I~II class
- scheduled for elective surgery requiring orotracheal intubation
Who cannot join
- with organ transplant operations
- with thoracic and cardiac vascular surgery
- with severe cadiac or pulmonary disease
- BMI over 35kg/m2
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study
Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.
Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.
The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.
- Conditions
- Airway Management
- Being tested
- Tongue Root Retractor, Conventional Fibroscope
- Keywords
- fibreoptic intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Root RetractorDevice
Fibroptic endutracheal intubation will be performed with tongue root retractor.
Conventional FibroscopeDevice
Fibroptic endutracheal intubation will be performed in conventional way.
| Study group | Role | What they receive |
|---|---|---|
| Tongue Root Retractor | Experimental | Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors. Receives: Device: Tongue Root Retractor |
| Conventional Fibroscope | Active comparator | Patients in this arm will receive fibroscopic endotracheal intubation without any other devices. Receives: Device: Conventional Fibroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intubation.
Successs of intubation at different attempts.
Measured: From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.
Secondary outcomes (4)
Epiglottis level
Airway clearance at the epiglottis level was assessed by observing whether the epiglottis was in contact with the posterior pharyngeal wall
Measured: within 30 seconds after the beginning of fibroscopy
Carina time
time from the beginning of fibroscopy to the confirmation of the carina
Measured: within 90 seconds
Successful Intubation on 1st Attemp
the success rate on 1st attempt
Measured: from start of first intubation to end of first intubation attempt
Number of attempts for tube advancement
number of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation
Measured: within 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start10 Mar 2016
- Primary completion1 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengnian Ding, M.D., Study chair, The First Affiliated Hospital with Nanjing Medical UniversityXiaofei Cao, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityJunbei Wu, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343014
- Sponsor's protocol ID
- Fibroscopic intubation
- Acronym
- TRFI
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04343014
- Acronym / sponsor ID
- TRFI / Fibroscopic intubation
- Conditions
- Airway Management
- Keywords
- fibreoptic intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 13 Apr 2020 (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.
Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study.
Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.
The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongue Root Retractor | Experimental | Device: Tongue Root RetractorPatients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors. |
| Conventional Fibroscope | Active comparator | Device: Conventional FibroscopePatients in this arm will receive fibroscopic endotracheal intubation without any other devices. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 to 70 years
- ASA graded I~II class
- scheduled for elective surgery requiring orotracheal intubation
Key exclusion criteria (4 listed)
- with organ transplant operations
- with thoracic and cardiac vascular surgery
- with severe cadiac or pulmonary disease
- BMI over 35kg/m2
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 |
|---|---|---|
| Tongue Root RetractorFibroptic endutracheal intubation will be performed with tongue root retractor. | Device | Tongue Root Retractor |
| Conventional FibroscopeFibroptic endutracheal intubation will be performed in conventional way. | Device | Conventional Fibroscope |
Primary outcome
Feasibility of intubation.
Time frame: From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.
Successs of intubation at different attempts.
4 secondary outcomes
Epiglottis level
Time frame: within 30 seconds after the beginning of fibroscopy
Carina time
Time frame: within 90 seconds
Successful Intubation on 1st Attemp
Time frame: from start of first intubation to end of first intubation attempt
Number of attempts for tube advancement
Time frame: within 120 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Zhengnian Ding, M.D. study chair
The First Affiliated Hospital with Nanjing Medical University
Xiaofei Cao, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
Junbei Wu, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Root Retractor and Conventional Fibroscope in people with Airway Management, run by The First Affiliated Hospital with Nanjing Medical University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of intubation. (time frame: From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2021; AzTrials last refreshed its copy on 4 Nov 2026.