Airway Management Clinical Trial
— TRFIOfficial title:
Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study
Verified date | February 2021 |
Source | The First Affiliated Hospital with Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study. Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study. The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 10, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - aged 18 to 70 years - ASA graded I~II class - scheduled for elective surgery requiring orotracheal intubation Exclusion Criteria: - with organ transplant operations - with thoracic and cardiac vascular surgery - with severe cadiac or pulmonary disease - BMI over 35kg/m2 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of intubation. | Successs of intubation at different attempts. | From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes. | |
Secondary | Epiglottis level | Airway clearance at the epiglottis level was assessed by observing whether the epiglottis was in contact with the posterior pharyngeal wall | within 30 seconds after the beginning of fibroscopy | |
Secondary | Carina time | time from the beginning of fibroscopy to the confirmation of the carina | within 90 seconds | |
Secondary | Successful Intubation on 1st Attemp | the success rate on 1st attempt | from start of first intubation to end of first intubation attempt | |
Secondary | Number of attempts for tube advancement | number of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation | within 120 seconds |
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