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

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)

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: ambu ascope; Device: fibreroptic bronchoscope

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 11451
      • Kasr Alini Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ambu scope; intubation of cancer tongue patients with ambu scope device	Device: ambu ascope; nasal route intubation by the device in fixed cancer tongue patients; Other Names: Ambu® aScope™
ACTIVE_COMPARATOR: fiberoptic; intubation of cancer tongue patients with fiberoptic device	Device: fibreroptic bronchoscope; nasal route intubation by the device in fixed cancer tongue patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: mahmoud salem soliman
• Collaborators: Cairo University
• Investigators: Principal Investigator: Ekramy M Abdelghafar, MD, Cairo University

Publications and helpful links

General Publications

• Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6. doi: 10.1016/0195-6701(95)90059-4.
• 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.
• 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. doi: 10.1111/j.1365-2044.2006.04652.x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): May 5, 2020
• Study Completion (ACTUAL): May 19, 2020

Study Registration Dates

• First Submitted: June 22, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (ACTUAL): June 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: intubation in cancer tongue

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data for primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: 3 months
• IPD Sharing Access Criteria: open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No