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

NCT ID: NCT06198634

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laryngeal Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ashrakt Ahmed Mahmoud

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ashrakt Ahmed, master

Role: CONTACT

01111709156

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33643969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5459079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32130509 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

intubation laryngeal hazard

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
NCT03250975 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Oral Care Apparatus for Intubated Patients
NCT06709183 ENROLLING_BY_INVITATION NA