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

Intubation Clinical Trial

Official title:

Method Evaluation Study of Truview PCD Versus MacIntosh Laryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530152
• Other study ID #: NCT-20110006
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: June 18, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation

Intervention

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.

Locations

Country	Name	City	State
Denmark	Per Henrik Lambert	Ålborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cormack Lehane (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.	The seconds during intubation where the anaesthesiologist view the vocal cords to determine the CL grade..	No