Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Seltz Kristensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01100957
First received: March 25, 2010
Last updated: August 23, 2011
Last verified: March 2010
  Purpose

The study is in two parts

Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.

Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.

The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.


Condition Intervention
Tracheal Intubation
Difficult Airway
Procedure: tracheal intubation with a single use flexible videoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • time for completion of intubation [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
    This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study


Secondary Outcome Measures:
  • time for preparing and cleaning the endoscopes [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    this is measured in the hour before and after the intubation

  • number of intubation attempts [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    measured during the intubation

  • success rate of endotracheal intubation [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    measured during the intubation

  • total time for the intubation-procedure inclusive the time for distributing local analgesics [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    measured during the intubation

  • Quality of the image from the videoscope [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    Observed immediately before, and during, the intubation

  • Evaluation of the insertion cord of the flexible scope [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    measured during the intubation

  • Evaluation of the working-/-injection-channel [ Time Frame: september 2010 ] [ Designated as safety issue: No ]
    measured during the intubation


Estimated Enrollment: 60
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional flexible videoscope for intubation Procedure: tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope
Experimental: Single-patient flexible endoscope
Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm
Procedure: tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Study part 1:

    • Patients scheduled for tracheal intubation and predicted to have a normal airway
    • ASA class I, II or III
    • >18 years
  2. Study part 2:

    • Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
    • ASA class I, II or III
    • >18 years

Exclusion Criteria:

  1. Study part 1:

    • Massive bleeding from the mouth
    • Previously abandoned flexible optical intubation
  2. Study part 2:

    • Massive bleeding from the mouth
    • Previously abandoned flexible optical intubation
    • Patients with audible stridor
    • Patients with dyspnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100957

Locations
Denmark
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Michael S Kristensen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Michael Seltz Kristensen, M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01100957     History of Changes
Other Study ID Numbers: aScope-1+2 a, H-A-2009-022
Study First Received: March 25, 2010
Last Updated: August 23, 2011
Health Authority: Denmark:De Videnskabsetiske komiteer i Region Hovedstaden

ClinicalTrials.gov processed this record on April 16, 2014