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出境医 / 临床实验 / Evaluation of the Efficacy of Ambu® aScope2 for Intubation in Cancer Tongue

Evaluation of the Efficacy of Ambu® aScope2 for Intubation in Cancer Tongue

Study Description
Brief Summary:
This study compares the ascope2 with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)

Condition or disease Intervention/treatment Phase
Difficult Intubation Device: ambu ascope2 Device: fibreroptic bronchoscope Not Applicable

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 ascope2 group The timer will be started (T0), when touching the fiberscope or a scope2. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel assignment
Masking: Single (Participant)
Masking Description: patient will be under general anesthesia
Primary Purpose: Other
Official Title: Randomized- Single Blind Trial of Ambu ascope2 and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : May 5, 2020
Actual Study Completion Date : May 19, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: ambu scope2
intubation of cancer tongue patients with ambu scope2 device
 Device: ambu ascope2
nasal route intubation by the device in fixed cancer tongue patients
Other Name: Ambu® aScope™ 2
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
Outcome Measures
Primary Outcome Measures :
  1. time of successful intubation [ Time Frame: 5 minutes ]

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

    .



Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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Egypt
Kasr Alini Univeristy Hospital
Cairo, Giza, Egypt, 11451
Sponsors and Collaborators
mahmoud salem soliman
Cairo University
Investigators
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Principal Investigator: Ekramy M Abdelghafar, MD Cairo University
Tracking Information
First Submitted Date  ICMJE June 22, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		time of successful intubation [ Time Frame: 5 minutes ]
measuring time in seconds for reaching carina and time for successful intubation .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • quality of vision [ Time Frame: 5 minutes ]
    subjective assessment by operator
  • incidence of complications [ Time Frame: 15 minutes ]
    accounting number of desaturation , bleeding , hypoxia .
  • easiness of intubation [ Time Frame: 5 minutes ]
    subjective assessment
  • number of intubation trials [ Time Frame: 30 minutes ]
    counting number of intubation in each group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Ambu® aScope2 for Intubation in Cancer Tongue
Official Title  ICMJE Randomized- Single Blind Trial of Ambu ascope2 and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer
Brief Summary This study compares the ascope2 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 ascope2 group The timer will be started (T0), when touching the fiberscope or a scope2. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
parallel assignment
Masking: Single (Participant)
Masking Description:
patient will be under general anesthesia
Primary Purpose: Other
Condition  ICMJE Difficult Intubation
Intervention  ICMJE
  • Device: ambu ascope2
    nasal route intubation by the device in fixed cancer tongue patients
    Other Name: Ambu® aScope™ 2
  • Device: fibreroptic bronchoscope
    nasal route intubation by the device in fixed cancer tongue patients
Study Arms  ICMJE
  • Experimental: ambu scope2
    intubation of cancer tongue patients with ambu scope2 device
    Intervention: Device: ambu ascope2
  • Active Comparator: fiberoptic
    intubation of cancer tongue patients with fiberoptic device
    Intervention: Device: fibreroptic bronchoscope
Publications *
  • Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6.
  • 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):1533-5, table of contents.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2020) 		100
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		104
Actual Study Completion Date  ICMJE May 19, 2020
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999476
Other Study ID Numbers  ICMJE intubation in cancer tongue
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified participant data for primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 3 months
Access Criteria: open
Responsible Party mahmoud salem soliman, Cairo University
Study Sponsor  ICMJE mahmoud salem soliman
Collaborators  ICMJE Cairo University
Investigators  ICMJE
Principal Investigator: Ekramy M Abdelghafar, MD Cairo University
PRS Account Cairo University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP