Nasotracheal Intubation With VL vs DL in Infants Trial

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.

Conditions

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

Interventions

DEVICE

Nasotracheal intubation

Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

Sponsors & Collaborators

• Children's Hospital Colorado

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Children's Medical Center Dallas

  collaborator OTHER

• Dell Children's Medical Center of Central Texas

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

• Annery Garcia-Marcinikiewicz, MD · The Children Hospital of Philadelphia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

365 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-06

Primary Completion

2025-02-25

Completion

2025-02-25

Countries

• United States

Study Locations