The Videolaryngoscopy in Small Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Videolaryngoscopy in Small Infants (VISI) Trial

Conditions
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Surgery, Anesthesia, Endotracheal

Intervention / Treatment
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* Device: Video Laryngoscopy for ET placement
* Device: Direct Laryngoscopy for ET Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males or females age 0 to <12 months. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician. Subject/Parental/guardian permission (informed consent). Inclusion for clinician participants: 1) Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident Exclusion Criteria History of difficult intubation History with abnormal airway Predictive of difficult intubation upon physical examination Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, multi-center parallel group trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Video Laryngoscopy for endotracheal (ET) Placement<br>Device: Storz C-MAC Video Laryngoscope | Device: Video Laryngoscopy for ET placement<br>* Tracheal intubation performed with the Storz C-Mac Video Laryngoscope<br>Device: Direct Laryngoscopy for ET Placement<br>* Tracheal Intubation performed with the Miller Blade<br>|
| Active Comparator: Direct Laryngoscopy for ET Placement<br>Device: Miller Laryngoscope | Device: Video Laryngoscopy for ET placement<br>* Tracheal intubation performed with the Storz C-Mac Video Laryngoscope<br>Device: Direct Laryngoscopy for ET Placement<br>* Tracheal Intubation performed with the Miller Blade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Success in the First Attempt | comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL | at the time of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia | Comparing the lowest oxygen saturation during tracheal intubation with VL vs. DL | At the time of intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngoscope, intubation, first attempt success, oxygen saturation, airway management, Videolaryngoscopy, Direct laryngoscopy