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

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center, Houston, December 2008

First Received: December 5, 2008 No Changes Posted

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00803751

Purpose

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.

Condition	Intervention
Laryngoscopy	Device: Use of Truview EVO2 laryngoscope Device: Use of the Macintosh laryngoscope

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Quality of laryngeal view obtained. [ Time Frame: during laryngoscopy prior to intubation ] [ Designated as safety issue: No ]
Ease of intubation [ Time Frame: during intubation prior to surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time taken for intubation [ Time Frame: throughout the intubation procedure ] [ Designated as safety issue: No ]
Presence of bleeding gums or oral injury [ Time Frame: 2 hours after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Truview intubation: Experimental Receive laryngoscopy with Macintosh blade first and is immediately followed by laryngoscopy and intubation with Truview	Device: Use of Truview EVO2 laryngoscope will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope
Macintosh intubation: Active Comparator Use the Truview laryngoscope first immediately followed by laryngoscopy and intubation with the Macintosh laryngoscope	Device: Use of the Macintosh laryngoscope Intubation using the traditional Macintosh laryngoscope

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Documented difficult airway
Facial deformities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803751

Contacts

Contact: Maria Matuszczak, MD

713-500-5075

Maria.Matuszczak@uth.tmc.edu

Locations

United States, Texas
Memorial Hermann Hospital - Texas Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: Maria Matuszczak, MD 713-500-5075
Principal Investigator: Maira Matuszczak, MD

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Maria Matuszczak, MD

The University of Texas Health Science Center, Houston

More Information

Additional Information:

Truphatek - Manufacturer's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas Health Science Center at Houston ( Maria Matuszczak, MD (Principal Investigator) )
Study ID Numbers:	Infant Truview
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00803751 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Laryngoscopy [E04.580.373]

ClinicalTrials.gov processed this record on May 07, 2009