Evaluation of the Efficacy of Ambu® aScope for Intubation in Cancer Tongue

Study Overview
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Brief Summary
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This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)

Detailed Description
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patient will be allocated into two group according to the type of endoscope used group (F) fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced through the nostril and advanced through the vocal cords, once carina identified the time will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the end-tidal co2 curve on capnography (T2).

Official Title
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Randomized- Single Blind Trial of Ambu Ascope and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: ambu ascope
* Device: fibreroptic bronchoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of ASA physical status I and II who will be scheduled for posterior third fixed cancer tongue with severe difficult airway requiring naso-tracheal intubation aged 18-70 years Exclusion Criteria: ASA 2 or 4 pregnant

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ambu scope<br>intubation of cancer tongue patients with ambu scope device | Device: ambu ascope<br>* nasal route intubation by the device in fixed cancer tongue patients<br>* Other names: Ambu® aScope™;|
| Active Comparator: fiberoptic<br>intubation of cancer tongue patients with fiberoptic device | Device: fibreroptic bronchoscope<br>* nasal route intubation by the device in fixed cancer tongue patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of successful intubation | measuring time in seconds for reaching carina and time for successful intubation . | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of vision | subjective assessment by operator | 5 minutes | 
| incidence of complications | accounting number of desaturation , bleeding , hypoxia . | 15 minutes | 
| easiness of intubation | subjective assessment | 5 minutes | 
| number of intubation trials | counting number of intubation in each group | 30 minutes |