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Completed

NCT Number: NCT00803751

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

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.

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Key information

Conditions

Laryngoscopy

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Truview EVO2 laryngoscope

Device

will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope

Macintosh laryngoscope

Device

Intubation using the traditional Macintosh laryngoscope

Primary outcomes

  1. Quality of Laryngeal View Obtained on Comarck Lehane Classification

    Time frame: 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.

  2. Number of Intubation Attempts

    Time frame: during intubation prior to surgery

    Number of participants with the indicated number of intubation attempts (1/2/3)

  3. Quality of Laryngeal View Obtained With 2nd Laryngoscopy

    Time frame: 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 outcomes

  1. Time Taken for Intubation

    Time frame: throughout the intubation procedure

  2. POGO Score With 1st Laryngoscopy

    Time frame: 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.

  3. POGO Score With 2nd Laryngoscopy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: Truview

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2008
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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