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

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999476
• Other study ID #: intubation in cancer tongue
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: October 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 19, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• ambu ascope
nasal route intubation by the device in fixed cancer tongue patients
• fibreroptic bronchoscope
nasal route intubation by the device in fixed cancer tongue patients

Locations

Country	Name	City	State
Egypt	Kasr Alini Univeristy Hospital	Cairo	Giza

Sponsors (2)

Lead Sponsor	Collaborator
mahmoud salem soliman	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33. — View Citation

Marfin AG, Iqbal R, Mihm F, Popat MT, Scott SH, Pandit JJ. Determination of the site of tracheal tube impingement during nasotracheal fibreoptic intubation. Anaesthesia. 2006 Jul;61(7):646-50. — View Citation

Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of successful intubation	measuring time in seconds for reaching carina and time for successful intubation; .	5 minutes
Secondary	quality of vision	subjective assessment by operator	5 minutes
Secondary	incidence of complications	accounting number of desaturation , bleeding , hypoxia .	15 minutes
Secondary	easiness of intubation	subjective assessment	5 minutes
Secondary	number of intubation trials	counting number of intubation in each group	30 minutes