Status:
COMPLETED
Nasotracheal Intubation With VL vs DL in Infants Trial
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Children's Hospital Colorado
Seattle Children's Hospital
Conditions:
Intubation Complication
Intubation; Difficult or Failed
Eligibility:
All Genders
1-365 years
Phase:
NA
Brief 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 Uni...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT05433155
Start Date
June 6 2022
End Date
February 25 2025
Last Update
March 28 2025
Active Locations (8)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203-6869