None listed
Conditions
Interventions
Experimental group:Single-use, cuff-free, self-adaptive tracheal tube with unconventional shape (VCuff / VCuff P / VCuff J)
Control group:Single-use sterile endotracheal tube (ETT-J42, etc.)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years, both sexes. 2. Patients scheduled for elective surgery requiring orotracheal intubation under general anesthesia. 3. Planned surgical position: supine, with expected operative duration between 2 and 6 hours. 4. American Society of Anesthesiologists (ASA) physical status I or II. 5. Voluntarily participate and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy to product materials (PVC, polyurethane). 2. Pre-existing severe laryngeal edema/inflammation, hemorrhage, subglottic hematoma, laryngeal trauma, or chemical/thermal burns. 3. Pre-existing laryngeal cyst, neoplasm, or space-occupying lesion. 4. Preoperative diagnosis of upper respiratory tract infection or pneumonia. 5. Pre-existing significant sore throat, cough, hoarseness, dysphagia, or dysphonia. 6. Bleeding disorders (e.g., hemophilia, thrombocytopenic purpura). 7. External compression of trachea due to neck or chest diseases. 8. Scheduled surgery involving head, neck, maxillofacial, or laryngopharyngeal region (including previous surgery history). 9. Anticipated difficult airway. 10. Severe cardiovascular, respiratory, liver, or kidney diseases. 11. Severe liver dysfunction (ALT/AST > 2.5×ULN), severe renal dysfunction (creatinine/urea > 2×ULN), or severe coagulation disorder (PT >1.5×ULN, APTT >1.5×ULN). 12. Planned use of laser or active electrosurgical electrodes near the tube placement area. 13. Expected postoperative transfer to ICU. 14. Pregnancy or lactation. 15. Participation in another clinical trial within the past month. 16. Any other condition judged by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-extubation airway injury rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity and incidence of postoperative sore throat;Severity and incidence of postoperative cough;Severity and incidence of postoperative hoarseness;ntubation success rate;Evaluation of equipment performance; | — |
Countries
China
Contacts
Public ContactJinbao Li
Shanghai General Hospital
Outcome results
None listed