NCT05433155

Nasotracheal Intubation With VL vs DL in Infants Trial

Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 1 Day – 365 Days
• Healthy volunteers: Not accepted

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

Conditions

• Intubation Complication
• Intubation; Difficult or Failed
• Hypoxia
• Hypoxemia
• Anesthesia Intubation Complication
• Pediatric HD

Interventions

Type	Name	Description
DEVICE	Nasotracheal intubation	Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Timeline

• Start date: 2022-06-06
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2022-06-27
• Last updated: 2025-03-28

Locations

8 sites across 1 country: United States