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

NCT ID: NCT01530152

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

Brief Summary

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.

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.

Conditions

Intubation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

laryngoscopi; generel anaesthesia; lidocain spray

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Per Henrik Lambert

Senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Per Henrik Lambert

Aalborg, Ålborg, Denmark

Countries

Denmark

Other Identifiers

NCT-20110006

Identifier Type: -

Identifier Source: org_study_id