Anesthesia Intubation Complication, Hypoxemia, Hypoxia, Intubation Complication, Intubation; Difficult or Failed, Pediatric HD
Conditions
Keywords
Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization, Multi-center
Brief summary
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
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
Interventions
DEVICENasotracheal intubation
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy
Sponsors
Children's Hospital Colorado
Seattle Children's Hospital
Baylor College of Medicine
Children's Medical Center Dallas
Dell Children's Medical Center of Central Texas
Children's National Research Institute
Vanderbilt University Medical Center
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Blinding of the device for clinicians and study staff is not feasible in this study. Participants will be blinded. The statisticians will be blinded at the time of generating the randomization schedule and remain blinded at the time of analysis.
Intervention model description
Prospective, randomized, multi-center parallel group trial
Eligibility
Sex/Gender
ALL
Age
1 Days to 365 Days
Healthy volunteers
No
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) For clinician participants: \- Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VL first attempt success rate | 24 hours | Direct observation of intubation in the OR and medical record review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of failed NTI (conversion to oral intubation) | 24 hours | Direct observation of intubation in the OR and medical record review |
| Incidence of failure to intubate with assigned device | 24 hours | Direct observation of intubation in the OR and medical record review |
| Incidence of complications over all attempts including non-severe and severe complications | 24 hours | Direct observation of intubation in the OR and medical record review |
| Number of attempts for successful intubation | 24 hours | Direct observation of intubation in the OR and medical record review |
| Incidence of additional techniques | 24 hours | Direct observation of intubation in the OR and medical record review |
| Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes | 24 hours | Direct observation of intubation in the OR and medical record review |
| Incidence of 1st-attempt complications | 24 hours | Direct observation of intubation in the OR and medical record review |
Countries
United States
Outcome results
None listed