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

NCT01530152 | Completed

• 1 other identifier: NCT-20110006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Keywords

Truwiev PCD laryngoscope; Macintosh laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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..

Interventions

Truwiev PCD laryngoscope PROCEDURE

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.

Also known as: laryngoscopi, generel anaesthesia, lidocain spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Per Henrik Lambert

Aalborg, Ålborg, 9000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: February 9, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

DK (1)