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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03999476

Enrollment

100

Registered

2019-06-26

Start date

2018-08-01

Completion date

2020-05-19

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intubation

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).

Interventions

DEVICEambu ascope

nasal route intubation by the device in fixed cancer tongue patients

DEVICEfibreroptic bronchoscope

nasal route intubation by the device in fixed cancer tongue patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Masking description

patient will be under general anesthesia

Intervention model description

parallel assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
time of successful intubation	5 minutes	measuring time in seconds for reaching carina and time for successful intubation .

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026