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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014