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N/A N=49 Randomized Single-blind Supportive Care

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

Laryngoscopy

Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Quality of Laryngeal View Obtained on Comarck Lehane Classification — 21; 13; 3; 5 Participants — p=0.17

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Truview EVO2 laryngoscope (Device); Macintosh laryngoscope (Device)
Age
Pediatric
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Laryngeal View Obtained on Comarck Lehane Classification
21; 13; 3; 5; 1; 4 0.17
PRIMARY
Number of Intubation Attempts
17; 23; 4; 2; 2; 1 0.45
PRIMARY
Quality of Laryngeal View Obtained With 2nd Laryngoscopy
10; 21; 7; 2; 9; 0 <0.001 sig
SECONDARY
Time Taken for Intubation
25.23; 28.33 0.36
SECONDARY
POGO Score With 1st Laryngoscopy
93.65; 73.81 0.002 sig
SECONDARY
POGO Score With 2nd Laryngoscopy
74.3; 98.0 0.0004 sig

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00803751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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