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Completed

NCT Number: NCT01100957

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

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.

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Key information

Conditions

Tracheal Intubation Difficult Airway

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study part 1:
  • Patients scheduled for tracheal intubation and predicted to have a normal airway
  • ASA class I, II or III
  • >18 years
  • 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

  • Study part 1:
  • Massive bleeding from the mouth
  • Previously abandoned flexible optical intubation
  • Study part 2:
  • Massive bleeding from the mouth
  • Previously abandoned flexible optical intubation
  • Patients with audible stridor
  • Patients with dyspnea

Treatment and study plan

tracheal intubation with a single use flexible videoscope

Procedure

tracheal intubation with a single use flexible videoscope

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2010
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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