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

Not Applicable

Completed

• Conditions: Difficult Intubation
• Interventions: Device: ambu ascope; Device: fibreroptic bronchoscope

• Registration Number: NCT03999476
• Lead Sponsor: mahmoud salem soliman

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-06-22
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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
2. aged 18-70 years

Exclusion Criteria

1. ASA 2 or 4
2. pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ambu scope	ambu ascope	intubation of cancer tongue patients with ambu scope device
fiberoptic	fibreroptic bronchoscope	intubation of cancer tongue patients with fiberoptic device

Primary Outcome Measures

Name	Time	Method
time of successful intubation	5 minutes	measuring time in seconds for reaching carina and time for successful intubation; .

Secondary Outcome Measures

Name	Time	Method
quality of vision	5 minutes	subjective assessment by operator
easiness of intubation	5 minutes	subjective assessment
number of intubation trials	30 minutes	counting number of intubation in each group
incidence of complications	15 minutes	accounting number of desaturation , bleeding , hypoxia .

Trial Locations

Locations (1)

Kasr Alini Univeristy Hospital; 🇪🇬 Cairo, Giza, Egypt