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Comparison of a Single Use (Ambu aScope) and a Reusable Flexible Optical Scope for Intubation Through a Supraglottic Airway Device (Aura-i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02002364
Recruitment Status : Unknown
Verified May 2014 by Michael Seltz Kristensen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : December 5, 2013
Last Update Posted : May 21, 2014
Ambu A/S
Information provided by (Responsible Party):
Michael Seltz Kristensen, Rigshospitalet, Denmark

Brief Summary:

In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.

We hypothesize that intubation is obtained equally effective with both types of flexible scopes

Condition or disease Intervention/treatment Phase
General Anesthesia Procedure: tracheal intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device
Study Start Date : November 2013
Estimated Primary Completion Date : December 2014

Arm Intervention/treatment
Active Comparator: Single use flexible optical scope
Single use flexible optical scope , Ambu aScope
Procedure: tracheal intubation
Active Comparator: Multiple use flexible optical scope
Multiple use flexible optical scope
Procedure: tracheal intubation

Primary Outcome Measures :
  1. Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen [ Time Frame: Measured during tracheal intubation at induction of anesthesia ]

Secondary Outcome Measures :
  1. Number of attempts at placing the supraglottic-airway-device (SAD) [ Time Frame: From anesthesia induction and the following 10 minutes during securing of the airway ]
    an attempt is defined as the tip of the SAD passing the upper front teeth

  2. number of attempts at placing the flexible endoscope in the trachea [ Time Frame: From anesthesia induction and the following 10 minutes ]
  3. number of attempts at intubation [ Time Frame: From anesthesia induction and during the following 10 minutes during airway management ]
    An intubation attempt starts when the tip of the endotracheal tube passes the entrance to the SAD

  4. Total time for placement of SAD and endoscopy and intubation [ Time Frame: During induction of anesthesia and the following 10 minutes during airway management ]
  5. The best glottic view obtained [ Time Frame: After anesthesia induction and during the following 10 minutes during airway management ]
  6. The ease of passage of the flexible endoscope via the SAD [ Time Frame: During induction and airway management ]
  7. The anesthesiologists' satisfaction with the procedure [ Time Frame: During induction of anesthesia and within the 30 minutes hereafter ]
  8. The quality of the endoscopically obtained image [ Time Frame: During induction of anesthesia and the following 10 minutes during airway management ]
  9. Postoperative sore throat, dysphonia or dysphagia one hour after extubation [ Time Frame: AT the time 1 hour after extubation of the trachea ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
  • The patient must have one or two of the following predictors of difficult tracheal intubation:

    1. Modified Mallampati score > 2 (= "no parts of the Uvula is visible")
    2. a thyromental distance of less then or equal to 6.5 cms
    3. Combined movement in head and neck < 90 degrees
    4. Mouth-opening less the 4 cm (but must be larger then 2.5 cm)
    5. Inability to protrude the teeth n the lower jaw beyond the upper incisors
    6. BMI > 40 combined with a neck-circumference > 43 cms
    7. Upper-lip-bite-test > 2
    8. Previous difficult intubation or laryngoscopy (If more then two criteria are fulfilled the patient should be considered intubated awake instead. . But the upper-lip-bite-test and the prognation-beyond the incisors test represents a similar thing, namely the inability to sub-luxate the lower jaw, the if both these findings are positive it is only considered as counting for one.

Exclusion Criteria:

  • ASA physical status 4 or 5
  • contraindications for use of the SAD
  • Patients in whom intubation via a SAD has previously failed
  • Patients at risk of aspiration from the gastrointestinal channel
  • diseases in mouth, pharynx or larynx that precludes the use of a SAD
  • Patients in whom the cricothyroid membrane cannot be localized preanaesthetically
  • Patients in whom the doctor making the pre-anaesthetic evaluation finds in need of an awake intubation
  • Patients with possible Creutzfeldt-Jacobs disease or contraindication against the use of non-autoclavable equipment r risk of cross contamination with prions

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 identifier (NCT number): NCT02002364

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Contact: Michael S Kristensen, M.D. 0045 35458033

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Rigshospitalet, Denmark Recruiting
Copenhagen, Denmark, 2100
Contact: Michael S Kristensen, M.D.    0045 3445 8033   
Principal Investigator: Michael S Kristensen, M.D.         
Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Pierre Diemunsch, M.D.    0033 3 88 12 70 76   
Principal Investigator: Pierre Diemunsch, M.D.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Ambu A/S
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Principal Investigator: Michael S Kristensen Rigshospitalet, Denmark
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Responsible Party: Michael Seltz Kristensen, Consultant anaesthetist, Rigshospitalet, Denmark Identifier: NCT02002364    
Other Study ID Numbers: Journal nr. H-3-2012-001
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by Michael Seltz Kristensen, Rigshospitalet, Denmark:
tracheal intubation