Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit

Laryngeal Injury Clinical Trial

Official title:

Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198634
• Other study ID #: intubation laryngeal hazard
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Ashrakt Ahmed, master
• Phone: 01111709156
• Email: ashrkt1710[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

this study aims to detect the effect of endotracheal intubation on the larynx of the pediatric population in order to allow early detection of any hazards

Description:

Laryngeal lesions in children can be caused by a number of risk factors, including patient variables (prematurity, cardiac comorbidities), intubation method (in an emergency, by an unskilled team), and endotracheal tube use. (large size, cuffed tube), longer duration of intubation, infection, and insufficient patient sedation are just a few risk factors that can contribute to the development of laryngeal lesions in children. Endoscopic imaging of the larynx is essential in pediatric intubation-related laryngeal injuries since the intensity of symptoms may not necessarily be correlated with the extent of laryngeal injury that is actually present. Therefore, after intubation, we will evaluate neonates, babies, and kids who have laryngeal problems. The flexible fiberoptic nasopharyngo-laryngoscope, or laryngoscopy, is the preferred technique to assess these children's issues and represents a substantial development in the diagnosis of laryngeal pathology in children. As well as rigid bronchoscopy and direct laryngoscopy, under general anesthesia. The risks associated with anesthesia and instrumentation are two key drawbacks of this method. Without transferring to the operating room or requiring general anesthesia, the infant can be assessed in the outpatient clinic. Direct observation of the nasopharynx and larynx in a professional environment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

Inclusion Criteria:

1. Age: from 2 month to 18 year

2. Gender: both sexes will be included in the study

3. Endotracheal intubation in emergency or elective sitting for 24hr or more

Exclusion Criteria:

• 1-Congenital laryngeal lesions 2-Head and neck surgery 3-CNS infections 4-Craniofacial malformations

Related Conditions & MeSH terms

• Laryngeal Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Lambercy K, Pincet L, Sandu K. Intubation Related Laryngeal Injuries in Pediatric Population. Front Pediatr. 2021 Feb 10;9:594832. doi: 10.3389/fped.2021.594832. eCollection 2021. — View Citation

Lindholm CE. Prolonged endotracheal intubation. Acta Anaesthesiol Scand Suppl. 1970;33:1-131. doi: 10.1111/j.1399-6576.1969.tb00750.x. No abstract available. — View Citation

Veder LL, Joosten KFM, Schlink K, Timmerman MK, Hoeve LJ, van der Schroeff MP, Pullens B. Post-extubation stridor after prolonged intubation in the pediatric intensive care unit (PICU): a prospective observational cohort study. Eur Arch Otorhinolaryngol. 2020 Jun;277(6):1725-1731. doi: 10.1007/s00405-020-05877-0. Epub 2020 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of pediatric post intubation laryngeal lesions	measurement of presence or absence of laryngeal lesions (supraglottic,glottic,subglottic) post intubation in pediatrics using fiberoptic naso_pharyngeal_laryngoscopy	7_10 days post_intubation