Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT07444528
- Status
- Enrolling By Invitation
Conditions
- Infants Aged 0 Days to 12 Months Scheduled for Elective Surgery
- Neonates
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 365 Days
- Healthy Volunteers
- Accepted
Interventions
- Upper airway ultrasound — OTHERThe investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area.
Study Details
Upper airway ultrasound (UA-US) has been utilized in adults to predict difficult laryngoscopy (Cormick-Lehane view 3 or 4) and difficult tracheal intubation (DTI) (≥3 intubation attempts) and with moderate-to-high sensitivity and specificity. This bedside technique is reproducible, easy-to-do without any additional radiation risk, and was added to the most recent American Society of Anesthesiologists (ASA) Practice Guidelines for Difficult Airway Management in Adults. However, UA-US has only been applied to older children ages 5-12 and has not been examined in neonates and infants. Thus, the aim of this observational study using UA-US to predict difficult laryngoscopy and tracheal intubation in neonates and infants presenting for diagnostic, procedural or surgical care under general anesthesia requiring endotracheal intubation.
Key Dates
- Start date
- Mar 2, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 180 participants (estimated)
Arms
- Arm: neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockadeThe investigator will perform 6 UA-US measurements will be obtained with a high frequency linear array or curvilinear US probe following induction of anesthesia but prior to laryngoscopy or TI: distance from the skin to the epiglottis, distance from the skin to the hyoid bone, distance from skin to vocal cords, hyomental distance, tongue thickness, and tongue cross-sectional area. Following UA-US, oral tracheal intubation will occur with VL and neuromuscular blockade as clinical standard of care. At the time of tracheal intubation, the study team will record the percent of glottic opening (POGO) score and additional study endpoints.
Primary Outcome Measure
Percentage of Glottic Opening (POGO) score [ Time Frame: From enrollment to the end of successful tracheal intubation, approximately 30 minutes. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |