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

Launched by TIANJIN MEDICAL UNIVERSITY GENERAL HOSPITAL · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different methods of helping doctors insert a breathing tube (called endotracheal intubation) in patients who may have a difficult airway. The trial will specifically compare the use of a standard tube with a special tool called a TCI (tube core introducer) to see which method is safer and more effective in these challenging situations. The goal is to gather information that can help improve how doctors perform this procedure in real-life settings.

To participate in this trial, you must be an adult (18 years or older) scheduled for certain types of surgeries that require general anesthesia. Some of the key requirements include being in good health (Classes I-III according to the American Society of Anesthesiologists) and being able to understand the study's purpose and give your consent to join. If you have had certain medical issues recently, such as a stroke or severe heart problems, or if you have specific conditions affecting your airway, you may not be eligible to participate. During the study, participants will receive the assigned intubation method, and researchers will monitor how well it works in simulated difficult airway scenarios.

Gender

ALL

Eligibility criteria

• 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.