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

NCT03999476 | Completed

• 1 other identifier: intubation in cancer tongue
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

• time of successful intubation

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

  5 minutes

Secondary Outcomes (4)

• quality of vision

  5 minutes

• incidence of complications

  15 minutes

• easiness of intubation

  5 minutes

• number of intubation trials

  30 minutes

Study Arms (2)

ambu scope

EXPERIMENTAL

intubation of cancer tongue patients with ambu scope device

Device: ambu ascope

fiberoptic

ACTIVE COMPARATOR

intubation of cancer tongue patients with fiberoptic device

Device: fibreroptic bronchoscope

Interventions

ambu ascope DEVICE

nasal route intubation by the device in fixed cancer tongue patients

Also known as: Ambu® aScope™

ambu scope

fibreroptic bronchoscope DEVICE

nasal route intubation by the device in fixed cancer tongue patients

fiberoptic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ASA 2 or 4
• pregnant

Sponsors & Collaborators

• mahmoud salem soliman: lead
• Cairo University: collaborator

Study Sites (1)

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

Location

Related Publications (3)

• 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.

  PMID: 7560994 BACKGROUND

• 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.

  PMID: 15845720 BACKGROUND

• 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.

  PMID: 16792609 BACKGROUND

Study Officials

• Ekramy M Abdelghafar, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient will be under general anesthesia
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of intensive care unit at new kaser al ainy teaching hospital , lecterur of anaesthesia and intensive care cairo universty .

Model Details: parallel assignment

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 26, 2019
• Study Start: August 1, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 19, 2020
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months
• Access Criteria: open

Locations

EG (1)