Airway US in Predicting Difficult Pediatric Laryngoscopy

NCT06892405 | Not Yet Recruiting DMC

• 1 other identifier: 04-2024-201007
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Modified Mallampati Score (MMS).

  At Intubation

• The thyromental distance (TMD)

  preoperative

• The upper lip bite test (ULBT)

  Preoperative

Interventions

SonoSite™ S Series ultrasound DEVICE

US measurements will be performed in the pre-operating room a , patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.

Also known as: US

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Karim A Hamoda, MBBCH

CONTACT

01148066608

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, intensive care and pain management

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 24, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)