Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways

Intubation; Difficult or Failed Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115694
• Other study ID #: GWang025
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: Tianjin Medical University General Hospital
• Contact: Wei Cui,MD
• Phone: 13821678013
• Email: cuwe2528[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men =18 years of age or non-pregnant women;

2. 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;

3. Subject's American Society of Anesthesiologists physical status is I-III

4. 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.

Exclusion Criteria:

1. any cerebrovascular accident, such as stroke, transient ischemic attack (TIA), etc. occurred within 3 months;

2. patients with unstable angina pectoris or myocardial infarction within 3 months;

3. laryngeal mass, obstruction, maxillofacial fracture or deformity;

4. Full stomach, high intra-abdominal pressure, habitual vomiting, gastroesophageal reflux disease;

5. pharyngeal infection, hematoma, abscess, tonsil enlargement;

6. Upper respiratory tract infection within one month, fever, cough, runny nose, nasal congestion, etc.;

7. history of chronic airway inflammation, airway hyperresponsiveness or asthma;

8. diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);

9. severe complications of hypertension, such as arterial dissection, renal failure, cerebral hemorrhage, etc.;

10. reoperation within 3 months;

11. patients with contraindications or allergies to intraoperative drugs;

12. patients enrolled in other studies within 30 days;

13. poor adherence or the investigator's opinion that the patient was not suitable for the study.

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• TCI Articulating Introducer
use
• GlideRite® Rigid Stylet
use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day of surgery
Secondary	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	1 day of surgery
Secondary	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	1 day of surgery
Secondary	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.	24 hours after surgery