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

NCT00803751 | Completed Results

• 1 other identifier: Infant Truview
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngoscopy

Keywords

Laryngoscopy [E04.580.373]

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time Taken for Intubation

  throughout the intubation procedure

• POGO Score With 1st Laryngoscopy

  Before patient is intubated (few minutes before intubation)

• POGO Score With 2nd Laryngoscopy

  Before patient is intubated

Study Arms (2)

Truview intubation

EXPERIMENTAL

Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh

Device: Truview EVO2 laryngoscope

Macintosh intubation

ACTIVE COMPARATOR

Macintosh blade will be used first followed by laryngoscopy and intubation with the truview

Device: Macintosh laryngoscope

Interventions

Truview EVO2 laryngoscope DEVICE

will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope

Truview intubation

Macintosh laryngoscope DEVICE

Intubation using the traditional Macintosh laryngoscope

Macintosh intubation

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Documented difficult airway
• Facial deformities

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Links

• Truphatek - Manufacturer's website

Results Point of Contact

• Title: Maria Matuszczak
• Organization: UT Medical School, Houston

maria.matuszczak@uth.tmc.edu

713-498-2768

Study Officials

• Maria Matuszczak, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Anesthesiology

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2011-03

Locations

US (1)