Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.
Objectives: * Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old. * Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL. Study Design: Prospective, randomized, multi-center parallel group trial Setting/Participants: This will be a multi-center study with a minimum of four participating centers. The target population will be children ≤ 12 months age scheduled for elective surgery requiring general anesthesia with endotracheal intubation. Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL). Main study outcome measures are as follows: * The first intubation attempt success rate with each device * The number of attempts for successful intubation with each device * Complications associated with intubation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
566
Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Tracheal Intubation performed with the Miller Blade
Boston Children's Hospital
Boston, Massachusetts, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Princess Margaret Hospital For Children
Subiaco, Perth, Australia
Number of Participants With Success in the First Attempt
comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
Time frame: at the time of intubation
Hypoxia
Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL
Time frame: At the time of intubation
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