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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: TCI Articulating Introducer; Device: GlideRite® Rigid Stylet

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Cui,MD; Phone Number: 13821678013; Email: cuwe2528@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group：TCI Articulating Introducer; Tracheal intubation was performed using a TCI core under a visual laryngoscope	Device: TCI Articulating Introducer; use
Placebo Comparator: Control group：GlideRite® Rigid Stylet; Tracheal intubation was performed under a visual laryngoscope using a common tube core	Device: GlideRite® Rigid Stylet; use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: TCI Articulating Introducer; Endotracheal cannula; Simulated difficult airway
• Other Study ID Numbers: GWang025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No