NCT06198634

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 23, 2023

Last Update Submit

January 8, 2024

Conditions

Laryngeal Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

the patients will the pediatric population who underwent endotracheal intubation in emergency or elective sitting for 24hr or more

You may qualify if:

  • Age: from 2 month to 18 year
  • Gender: both sexes will be included in the study
  • Endotracheal intubation in emergency or elective sitting for 24hr or more

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 33643969BACKGROUND

  • 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.

    PMID: 5459079BACKGROUND

  • 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.

    PMID: 32130509BACKGROUND

Central Study Contacts

Ashrakt Ahmed, master

CONTACT

01111709156ashrkt1710@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2023

First Posted

January 10, 2024

Study Start

January 15, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

January 10, 2024

Record last verified: 2023-12