Airway US in Predicting Difficult Pediatric Laryngoscopy

NCT ID: NCT06892405

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-20
• Study Completion Date: 2027-05-01

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.

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).

Conditions

Airway Complication of Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SonoSite™ S Series ultrasound

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.

Intervention Type: DEVICE

Other Intervention Names

US

Eligibility Criteria

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,

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Professor of Anesthesia, intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university Pediatric hospital

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Central Contacts

Hala S Abdel-Ghaffar, MD

Role: CONTACT

hallasaad@yahoo.com

01003812011 ext. +20

Karim A Hamoda, MBBCH

Role: CONTACT

01148066608 ext. +20

Facility Contacts

Hala S Abdel-Ghaffar, MD

Role: primary

hallasaad@yahoo.com

+2 01003812011

Karim A Hamouda, MBBCH

Role: backup

01148066608

Other Identifiers

04-2024-201007

Identifier Type: -

Identifier Source: org_study_id