Intubation; Difficult or FailedNCT06115694
Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways
A study testing TCI Articulating Introducer and GlideRite® Rigid Stylet in people with Intubation; Difficult or Failed, run by Tianjin Medical University General Hospital.
Trial summary
Purpose: To compare the efficacy and safety of TCI tube core and ordinary tube core assisted tracheal intubation in simulating difficult airway under visual laryngoscope, and to provide reference for clinical application Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- TCI Articulating Introducer and GlideRite® Rigid Stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥18 years of age or non-pregnant women;
- For elective gynecological surgery or upper abdominal surgery under general anesthesia by oral tracheal intubation, the operation position was supine and the operation time was less than 3 hours;
- Subject's American Society of Anesthesiologists physical status is I-III
- Subjects who could understand the purpose of the trial, voluntarily participated and signed the informed consent form, and were willing to accept the designated follow-up.
Who cannot join
- any cerebrovascular accident, such as stroke, transient ischemic attack (TIA), etc. occurred within 3 months;
- patients with unstable angina pectoris or myocardial infarction within 3 months;
- laryngeal mass, obstruction, maxillofacial fracture or deformity;
- Full stomach, high intra-abdominal pressure, habitual vomiting, gastroesophageal reflux disease;
- pharyngeal infection, hematoma, abscess, tonsil enlargement;
- Upper respiratory tract infection within one month, fever, cough, runny nose, nasal congestion, etc.;
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- history of chronic airway inflammation, airway hyperresponsiveness or asthma;
- diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
- severe complications of hypertension, such as arterial dissection, renal failure, cerebral hemorrhage, etc.;
- reoperation within 3 months;
- patients with contraindications or allergies to intraoperative drugs;
- patients enrolled in other studies within 30 days;
- poor adherence or the investigator's opinion that the patient was not suitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways:A Prospective Randomized Controlled Multicenter Study
Purpose:
To compare the efficacy and safety of TCI tube core and ordinary tube core assisted tracheal intubation in simulating difficult airway under visual laryngoscope, and to provide reference for clinical application
Read the detailed description
Endotracheal intubation plays an important role in contemporary clinical anesthesia. Direct laryngoscope intubation is the traditional intubation method in anesthesia and emergency medical work. However, due to the constraints of the operator's technical level, the abnormal airway structure and the condition of patients, about 1.5% ~ 8.5% of the cases of intubation difficulties occur. It's even impossible to intubate. Failure of intubation can lead to major complications, including brain damage and death. When a tracheal intubation cannot be placed on the first two attempts, the intubation is classified as difficult, and repeated routine tracheal intubation may lead to morbidity in the patient, and the incidence of airway related complications increases significantly with the number of tracheal intubations. Difficult intubation accounted for 4% of operating room intubation and 10% of intubation outside the operating room. For patients with high glottis and short epiglottis, although the glottis can be seen, intubation is difficult to place. The effectiveness and safety of TCI tube assisted intubation under visual laryngoscope and ordinary tube tube assisted intubation in simulated difficult airway were compared to provide reference for clinical application.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- TCI Articulating Introducer, GlideRite® Rigid Stylet
- Keywords
- TCI Articulating Introducer, Endotracheal cannula, Simulated difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI Articulating IntroducerDevice
use
GlideRite® Rigid StyletDevice
use
| Study group | Role | What they receive |
|---|---|---|
| Experimental group：TCI Articulating Introducer | Active comparator | Tracheal intubation was performed using a TCI core under a visual laryngoscope Receives: Device: TCI Articulating Introducer |
| Control group：GlideRite® Rigid Stylet | Placebo comparator | Tracheal intubation was performed under a visual laryngoscope using a common tube core Receives: Device: GlideRite® Rigid Stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of intubation for the first time
To compare the success rate of first intubation in simulated difficult airway with TCI tube assisted by visual laryngoscope and ordinary tube.
Measured: 1 day of surgery
Secondary outcomes (3)
Overall success rate of intubation
Overall success rate of tracheal intubation assisted by TCI and conventional tube cores under video laryngoscope in all included patients
Measured: 1 day of surgery
Whether it is necessary to rotate the tracheal tube through the glottis
Whether it is necessary to rotate during tracheal intubation to successfully enter the airway through the glottis
Measured: 1 day of surgery
Throat complications
Whether the following conditions will occur after operation: oral mucosal injury: tracheal tube stained with blood or secretion with blood when extubation; Sore throat: patients complained of throat discomfort, manifested as slurred speech, foreign body sensation, cough, etc. Loose teeth; Difficulty speaking; Patients were followed up for 24 hours after surgery to see whether they still had dysphagia, nausea, vomiting, and cough.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115694
- Sponsor's protocol ID
- GWang025
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways:A Prospective Randomized Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT06115694
- Acronym / sponsor ID
- GWang025
- Conditions
- Intubation; Difficult or Failed
- Keywords
- TCI Articulating Introducer, Endotracheal cannula, Simulated difficult airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 3 Nov 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.
Purpose:
To compare the efficacy and safety of TCI tube core and ordinary tube core assisted tracheal intubation in simulating difficult airway under visual laryngoscope, and to provide reference for clinical application
Detailed description
Endotracheal intubation plays an important role in contemporary clinical anesthesia. Direct laryngoscope intubation is the traditional intubation method in anesthesia and emergency medical work. However, due to the constraints of the operator's technical level, the abnormal airway structure and the condition of patients, about 1.5% ~ 8.5% of the cases of intubation difficulties occur. It's even impossible to intubate. Failure of intubation can lead to major complications, including brain damage and death. When a tracheal intubation cannot be placed on the first two attempts, the intubation is classified as difficult, and repeated routine tracheal intubation may lead to morbidity in the patient, and the incidence of airway related complications increases significantly with the number of tracheal intubations. Difficult intubation accounted for 4% of operating room intubation and 10% of intubation outside the operating room. For patients with high glottis and short epiglottis, although the glottis can be seen, intubation is difficult to place. The effectiveness and safety of TCI tube assisted intubation under visual laryngoscope and ordinary tube tube assisted intubation in simulated difficult airway were compared to provide reference for clinical application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group：TCI Articulating Introducer | Active comparator | Device: TCI Articulating IntroducerTracheal intubation was performed using a TCI core under a visual laryngoscope |
| Control group：GlideRite® Rigid Stylet | Placebo comparator | Device: GlideRite® Rigid StyletTracheal intubation was performed under a visual laryngoscope using a common tube core |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men ≥18 years of age or non-pregnant women;
- For elective gynecological surgery or upper abdominal surgery under general anesthesia by oral tracheal intubation, the operation position was supine and the operation time was less than 3 hours;
- Subject's American Society of Anesthesiologists physical status is I-III
- Subjects who could understand the purpose of the trial, voluntarily participated and signed the informed consent form, and were willing to accept the designated follow-up.
Key exclusion criteria (13 listed)
- any cerebrovascular accident, such as stroke, transient ischemic attack (TIA), etc. occurred within 3 months;
- patients with unstable angina pectoris or myocardial infarction within 3 months;
- laryngeal mass, obstruction, maxillofacial fracture or deformity;
- Full stomach, high intra-abdominal pressure, habitual vomiting, gastroesophageal reflux disease;
- pharyngeal infection, hematoma, abscess, tonsil enlargement;
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 |
|---|---|---|
| TCI Articulating Introduceruse | Device | Experimental group：TCI Articulating Introducer |
| GlideRite® Rigid Styletuse | Device | Control group：GlideRite® Rigid Stylet |
Primary outcome
The success of intubation for the first time
Time frame: 1 day of surgery
To compare the success rate of first intubation in simulated difficult airway with TCI tube assisted by visual laryngoscope and ordinary tube.
3 secondary outcomes
Overall success rate of intubation
Time frame: 1 day of surgery
Whether it is necessary to rotate the tracheal tube through the glottis
Time frame: 1 day of surgery
Throat complications
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TCI Articulating Introducer and GlideRite® Rigid Stylet in people with Intubation; Difficult or Failed, run by Tianjin Medical University General Hospital.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Cui,MD (13821678013, cuwe2528@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success of intubation for the first time (time frame: 1 day of surgery). 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 3 Nov 2023.