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Completed

NCT Number: NCT03999476

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

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)

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Key information

Conditions

Difficult Intubation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ambu ascope

Device

nasal route intubation by the device in fixed cancer tongue patients

Other names: Ambu® aScope™

fibreroptic bronchoscope

Device

nasal route intubation by the device in fixed cancer tongue patients

Primary outcomes

  1. time of successful intubation

    Time frame: 5 minutes

    measuring time in seconds for reaching carina and time for successful intubation

    .

Secondary outcomes

  1. quality of vision

    Time frame: 5 minutes

    subjective assessment by operator

  2. incidence of complications

    Time frame: 15 minutes

    accounting number of desaturation , bleeding , hypoxia .

  3. easiness of intubation

    Time frame: 5 minutes

    subjective assessment

  4. number of intubation trials

    Time frame: 30 minutes

    counting number of intubation in each group

Sponsors and collaborators

Lead sponsor

mahmoud salem soliman

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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