Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants

NCT07444528 | Enrolling By Invitation

• 2 other identifiers: 25-023870PRJ-00001922
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonates; Infants Aged 0 Days to 12 Months Scheduled for Elective Surgery

Keywords

point of care ultrasound; airway ultrasound; difficult intubation; pediatric intubation

Outcome Measures

Primary Outcomes (1)

• Percentage of Glottic Opening (POGO) score

  (0-25%; \>25-50%; \>50-75%; \>75-100%). Lower POGO scores correlate with a worse view of the glottic opening (Cormack-Lehane III-IV) and difficult laryngoscopy.

  From enrollment to the end of successful tracheal intubation, approximately 30 minutes.

Secondary Outcomes (4)

• Difficult tracheal intubation

  From enrollment to the end of successful tracheal intubation, approximately 30 minutes.

• Time to successful intubation in seconds

  From enrollment to the end of successful tracheal intubation, approximately 30 minutes.

• First attempt success

  From enrollment to the end of successful tracheal intubation, approximately 30 minutes.

• Use of advancement maneuvers

  From enrollment to the end of successful tracheal intubation, approximately 30 minutes.

Study Arms (1)

neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockade

The 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.

Other: Upper airway ultrasound

Interventions

Upper airway ultrasound OTHER

The 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.

neonates and infants requiring oral tracheal intubation with VL and neuromuscular blockade

Eligibility Criteria

• Age: Up to 365 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants presenting for diagnostic or procedural care under general anesthesia requiring oral endotracheal intubation with video laryngoscopy and neuromuscular blockade.

You may qualify if:

• Neonates (chronological age 30 days) and infants (31 days to 365 days)
• ASA physical status I-IV
• Oral endotracheal intubation for surgical, diagnostic or interventional procedures with neuromuscular blockade
• Video laryngoscopy
• Patients with previously classified non-difficult airway (previous easy intubation)
• Patients with a previously classified difficult airway
• Patients with congenital heart disease
• Parental/guardian permission

You may not qualify if:

• ASA ≥V
• Emergency procedure
• Unable to be placed in supine position for study ultrasound
• Need for rapid sequence induction

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (23)

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Study Officials

• Elizabeth M O'Brien, MD, MAS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)