Nasotracheal Intubation With VL vs DL in Infants Trial
Purpose
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.
Conditions
- Intubation Complication
- Intubation; Difficult or Failed
- Hypoxia
- Hypoxemia
- Anesthesia Intubation Complication
- Pediatric HD
Eligibility
- Eligible Ages
- Between 1 Day and 365 Days
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective, randomized, multi-center parallel group trial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Videolaryngoscopy |
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope |
|
|
Active Comparator Direct Laryngoscopy |
Nasotracheal Intubation performed with the standard clinical direct blades |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT05433155
- Status
- Recruiting
- Sponsor
- Children's Hospital of Philadelphia
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