Nasotracheal Intubation With VL vs DL in Infants Trial
Completed · Not applicable
Conditions studied: Intubation Complication, Intubation; Difficult or Failed, Hypoxia, Hypoxemia, Anesthesia Intubation Complication, Pediatric HD
In brief
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.
Key facts
- Study ID
- NCT05433155
- Run by
- Children's Hospital of Philadelphia
- People needed
- 680
- Starts
- 2022-06-06
- Expected to finish
- 2025-02-25
- Last updated by the study team
- 2025-03-28
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- University of Texas at Austin Dell Children's Medical Center — Austin, Texas, United States
- Children's Medical Center Dallas — Dallas, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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