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

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ClinicalTrials.gov Identifier: NCT01100957
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Michael Seltz Kristensen, Rigshospitalet, Denmark

Brief Summary:

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 or disease Intervention/treatment Phase
Tracheal Intubation Difficult Airway Procedure: tracheal intubation with a single use flexible videoscope Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. time for completion of intubation [ Time Frame: September 2010 ]
    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 :
  1. time for preparing and cleaning the endoscopes [ Time Frame: september 2010 ]
    this is measured in the hour before and after the intubation

  2. number of intubation attempts [ Time Frame: september 2010 ]
    measured during the intubation

  3. success rate of endotracheal intubation [ Time Frame: september 2010 ]
    measured during the intubation

  4. total time for the intubation-procedure inclusive the time for distributing local analgesics [ Time Frame: september 2010 ]
    measured during the intubation

  5. Quality of the image from the videoscope [ Time Frame: september 2010 ]
    Observed immediately before, and during, the intubation

  6. Evaluation of the insertion cord of the flexible scope [ Time Frame: september 2010 ]
    measured during the intubation

  7. Evaluation of the working-/-injection-channel [ Time Frame: september 2010 ]
    measured during the intubation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: March 2010