An interventional study of Nasotracheal intubation in Intubation Complication, Intubation; Difficult or Failed and Hypoxia, sponsored by Children's Hospital of Philadelphia. Completed at 8 sites in United States. Open to participants aged 1 Day to 365 Days. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
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:
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 680 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
For clinician participants:
Exclusion Criteria:
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope
Device: Nasotracheal intubation
Nasotracheal Intubation performed with the standard clinical direct blades
Device: Nasotracheal intubation
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy
VL first attempt success rate
Direct observation of intubation in the OR and medical record review
Time frame: 24 hours
Number of attempts for successful intubation
Direct observation of intubation in the OR and medical record review
Time frame: 24 hours
Incidence of failed NTI (conversion to oral intubation)
Direct observation of intubation in the OR and medical record review
Time frame: 24 hours
Incidence of failure to intubate with assigned device
Direct observation of intubation in the OR and medical record review
Time frame: 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
Time frame: 24 hours
Incidence of 1st-attempt complications
Direct observation of intubation in the OR and medical record review
Time frame: 24 hours
Incidence of additional techniques
Direct observation of intubation in the OR and medical record review
Time frame: 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
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia