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

Not Applicable

Completed

• Conditions: Laryngoscopy
• Interventions: Device: Macintosh laryngoscope; Device: Truview EVO2 laryngoscope

• Registration Number: NCT00803751
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-02-18
• Status Verified: 2011-03
• Results First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh intubation	Macintosh laryngoscope	Macintosh blade will be used first followed by laryngoscopy and intubation with the truview
Truview intubation	Truview EVO2 laryngoscope	Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh

Primary Outcome Measures

Name	Time	Method
Quality of Laryngeal View Obtained on Comarck Lehane Classification	during laryngoscopy prior to intubation. Few minutes before intubation	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.
Number of Intubation Attempts	during intubation prior to surgery	Number of participants with the indicated number of intubation attempts (1/2/3)
Quality of Laryngeal View Obtained With 2nd Laryngoscopy	during laryngoscopy prior to intubation (few minutes prior to intubation)	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.

Secondary Outcome Measures

Name	Time	Method
POGO Score With 2nd Laryngoscopy	Before patient is intubated	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.
Time Taken for Intubation	throughout the intubation procedure
POGO Score With 1st Laryngoscopy	Before patient is intubated (few minutes before intubation)	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.

Trial Locations

Locations (1)

Memorial Hermann Hospital - Texas Medical Center; 🇺🇸 Houston, Texas, United States