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Method Evaluation Study of Truview Picture Capture Device(PCD) Versus MacIntosh Laryngoscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530152
First Posted: February 9, 2012
Last Update Posted: June 19, 2012
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.
Information provided by (Responsible Party):
Per Henrik Lambert, Aalborg Hospital
  Purpose

Aim:

The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.

The laryngoscopes are compared according to their ability to visualize the glottis area measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.

A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible decrease of the saturation will also be made.

Hypothesis:

The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes the intubation les difficult.

CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview PCD™ laryngoscope.


Condition Intervention
Intubation Procedure: Truwiev PCD laryngoscope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Method Evaluation Study of Truview PCD Versus MacIntosh Laryngoscope

Further study details as provided by Per Henrik Lambert, Aalborg Hospital:

Primary Outcome Measures:
  • Cormack Lehane (CL) grade [ Time Frame: The seconds during intubation where the anaesthesiologist view the vocal cords to determine the CL grade.. ]

    At the first laryngoscopy the patient is sprayed between plica vocalis with Lidocaine 4%, then the patient is ventilated by a mask. During the next laryngoscopy the intubation is performed (the endotracheal tube is placed in trachea).

    The patients are randomized by lottery as to which laryngoscope to be used first.

    After anesthesia induction, preceded by 3 minutes of preoxygenering, the first laryngoscope is used when spraying the patient with Lidocaine. Subsequently the patient is ventilated for 2 minutes, and then the intubation is performed by using the other laryngoscope.



Enrollment: 56
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Truwiev PCD laryngoscope

    The aim of the method evaluation study is a comparing study of Truview PCD™ laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.

    The laryngoscopes are compared according to their ability to visualize the glottis area measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade. (See figure 1.) A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible decrease of the saturation will also be made.

    Other Names:
    • laryngoscopi
    • generel anaesthesia
    • lidocain spray
Detailed Description:

The unexpected difficult intubation is, like the difficult mask ventilation, a feared complication to anaesthesia.

A difficult intubation occurs in approx. 1.2 - 3.8 percent of all anaesthesias .

The standard procedure of intubation in Denmark is to use the curved Macintosh blade. This method, however, has some limits, as it requires a direct view of the area of the vocal cords. For that reason we are looking for new methods of intubation that can give a better overview.

The Truview PCD™ laryngoscope is a commercially available laryngoscope with an integrated optical lens that can be connected to a camera head, and gives a better view of trachea during intubation under a general anaestetic. Furthermore it is possible to connect 8-10 liters of oxygen per minute to the Truview PCD™ laryngoscope, which will prevent fog on the viewtube and slow down the rate of desaturation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age who are to undergo a surgery at the ENT department, Aalborg Hospital.
  • Patients who understand and accept the trial information.
  • SARI score 2-5.

Exclusion Criteria:

  • SARI score 0-1 and > 5.
  • A need for acute initiation. (By acute initiation the endotracheal tube will be placed in trachea during the first laryngoscopy without prior spraying with local anesthesia).
  • If unexpected difficulties during the initiating anesthesia arise, the trial will be interrupted, and the patient will be treated according to the department's guidelines for the situation
  Contacts and Locations
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): NCT01530152


Locations
Denmark
Per Henrik Lambert
Ålborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
  More Information

Responsible Party: Per Henrik Lambert, Senior doctor, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01530152     History of Changes
Other Study ID Numbers: NCT-20110006
First Submitted: January 24, 2012
First Posted: February 9, 2012
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Per Henrik Lambert, Aalborg Hospital:
Truwiev PCD laryngoscope
Macintosh laryngoscope