Tongue Root Retractor For Fibroscopic Intubation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study

Conditions
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Airway Management

Intervention / Treatment
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* Device: Tongue Root Retractor
* Device: Conventional Fibroscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongue Root Retractor<br>Patients in this arm will receive fibroscopic endotracheal intubation with tongue root retractors. | Device: Tongue Root Retractor<br>* Fibroptic endutracheal intubation will be performed with tongue root retractor.<br>|
| Active Comparator: Conventional Fibroscope<br>Patients in this arm will receive fibroscopic endotracheal intubation without any other devices. | Device: Conventional Fibroscope<br>* Fibroptic endutracheal intubation will be performed in conventional way.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Carina time | time from the beginning of fibroscopy to the confirmation of the carina | within 90 seconds | 
| Successful Intubation on 1st Attemp | the success rate on 1st attempt | from start of first intubation to end of first intubation attempt | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibreoptic intubation