Nasotracheal Intubation With VL vs DL in Infants Trial

Study Overview
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Brief Summary
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Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.

Detailed Description
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The primary objectives of the study are to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations. Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight & > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members & rotating team members) on the association between treatment and outcomes Study Design: this is a prospective, randomized, multi-center parallel group trial Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI. Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct 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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Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial

Conditions
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Anesthesia Intubation Complication, Pediatric HD, Intubation Complication, Intubation; Difficult or Failed, Hypoxia, Hypoxemia

Intervention / Treatment
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* Device: Nasotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 0 -365 days Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician Plan to use a neuromuscular blocking drug prior to intubation as standard of care Parental/guardian permission (informed consent) Exclusion Criteria: Less than 36 weeks gestation Less than 2 kg History of difficult intubation History of abnormal airway Predictive of difficult intubation upon physical examination Preoperative endotracheal tube or tracheostomy Emergency cases

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 365 Days

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: Treatment
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: Videolaryngoscopy<br>Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope | Device: Nasotracheal intubation<br>* Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy<br>|
| Active Comparator: Direct Laryngoscopy<br>Nasotracheal Intubation performed with the standard clinical direct blades | Device: Nasotracheal intubation<br>* Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VL first attempt success rate | Direct observation of intubation in the OR and medical record review | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts for successful intubation | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Incidence of failed NTI (conversion to oral intubation) | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Incidence of failure to intubate with assigned device | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Incidence of complications over all attempts including non-severe and severe complications | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Incidence of 1st-attempt complications | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Incidence of additional techniques | Direct observation of intubation in the OR and medical record review | 24 hours | 
| Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes | Direct observation of intubation in the OR and medical record review | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation complications, Intubation technical difficulties, Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Randomization, Multi-center