A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients (Truview)

This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.

Study Overview

• Status: Completed
• Conditions: Laryngoscopy
• Intervention / Treatment: Device: Truview EVO2 laryngoscope; Device: Macintosh laryngoscope

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital - Texas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age less than one year
2. Requiring general anesthesia and orotracheal intubation
3. Weight less than 10 kg
4. ASA class 1-3

Exclusion Criteria:

1. Documented difficult airway
2. Facial deformities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Truview intubation; Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh	Device: Truview EVO2 laryngoscope; will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
Active Comparator: Macintosh intubation; Macintosh blade will be used first followed by laryngoscopy and intubation with the truview	Device: Macintosh laryngoscope; Intubation using the traditional Macintosh laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Laryngeal View Obtained on Comarck Lehane Classification	The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.	during laryngoscopy prior to intubation. Few minutes before intubation
Number of Intubation Attempts	Number of participants with the indicated number of intubation attempts (1/2/3)	during intubation prior to surgery
Quality of Laryngeal View Obtained With 2nd Laryngoscopy	The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.	during laryngoscopy prior to intubation (few minutes prior to intubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Taken for Intubation		throughout the intubation procedure
POGO Score With 1st Laryngoscopy	POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.	Before patient is intubated (few minutes before intubation)
POGO Score With 2nd Laryngoscopy	POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.	Before patient is intubated

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Maria Matuszczak, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

Helpful Links

• Truphatek - Manufacturer's website

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Laryngoscopy [E04.580.373]
• Other Study ID Numbers: Infant Truview