Airway US in Predicting Difficult Pediatric Laryngoscopy (AirwayUS)

Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.

The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Device: SonoSite™ S Series ultrasound

Detailed Description

Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).

• Study Type: Observational
• Enrollment (Estimated): 49

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: Karim A Hamoda, MBBCH; Phone Number: +20 01148066608

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, 715715
      • Assiut University Pediatric Hospital
      • Contact: Hala S Abdel-Ghaffar, MD; Phone Number: +2 01003812011; Email: hallasaad@yahoo.com
      • Contact: Karim A Hamouda, MBBCH; Phone Number: 01148066608

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children aged 2-6 years, ASA I, II who will be scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Description

Inclusion Criteria:

• Gender both males and females
• ASA Class I and II
• Age 2 years to 6
• Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.

Exclusion Criteria:

• Congenital upper airway malformation,
• Head and neck swellings,
• Scars,
• Radiation to the neck,
• Tracheotomy,

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords).	To evaluate the accuracy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Namely the DSH, DSE, DSG, DSH+DSE, and DSH-DSE in prediction of difficult laryngoscopy.	Preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Modified Mallampati Score (MMS).	The Modified Mallampati Score (MMS): Class I: Soft palate, uvula, fauces, pillars visible.; Class II: Soft palate, major part of uvula, fauces visible.; Class III: Soft palate, base of uvula visible.; Class IV: Only hard palate visible.	At Intubation
The thyromental distance (TMD)	The thyromental distance (TMD) is the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended measured by a ruler.	preoperative
The upper lip bite test (ULBT)	The upper lip bite test (ULBT) performed by an anesthesiologist associated with this research and a specialist with more than 10 years of experience and in charge of the operating room.	Preoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2025
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 04-2024-201007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO