Clinical Trials Directory

Trials / Completed

CompletedNCT01530152

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

Method Evaluation Study of Truview PCD Versus MacIntosh Laryngoscope

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Aalborg University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDURETruwiev PCD laryngoscopeThe 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.

Timeline

Start date
2012-01-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2012-02-09
Last updated
2012-06-19

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01530152. Inclusion in this directory is not an endorsement.