Laryngeal InjuryNCT06198634
Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit
An observational study of Laryngeal Injury, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Laryngeal Injury
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: the patients will the pediatric population who underwent endotracheal intubation in emergency or elective sitting for 24hr or more
Who may be able to join
- 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
Who cannot join
- 1-Congenital laryngeal lesions 2-Head and neck surgery 3-CNS infections 4-Craniofacial malformations
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the detailed 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
- Conditions
- Laryngeal Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7_10 days post_intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngeal InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashrakt Ahmed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198634
- Sponsor's protocol ID
- intubation laryngeal hazard
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33643969Lindholm CE. Prolonged endotracheal intubation. Acta Anaesthesiol Scand Suppl. 1970;33:1-131. doi: 10.1111/j.1399-6576.1969.tb00750.x. No abstract available.
PubMed 5459079Veder 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.
PubMed 32130509
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06198634
- Acronym / sponsor ID
- intubation laryngeal hazard
- Conditions
- Laryngeal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- the patients will the pediatric population who underwent endotracheal intubation in emergency or elective sitting for 24hr or more
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1-Congenital laryngeal lesions 2-Head and neck surgery 3-CNS infections 4-Craniofacial malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of pediatric post intubation laryngeal lesions
Time frame: 7_10 days post_intubation
measurement of presence or absence of laryngeal lesions (supraglottic,glottic,subglottic) post intubation in pediatrics using fiberoptic naso_pharyngeal_laryngoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 33643969Lambercy 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.
- Background: PubMed 5459079Lindholm CE. Prolonged endotracheal intubation. Acta Anaesthesiol Scand Suppl. 1970;33:1-131. doi: 10.1111/j.1399-6576.1969.tb00750.x. No abstract available.
- Background: PubMed 32130509Veder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashrakt Ahmed, master (01111709156, ashrkt1710@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of pediatric post intubation laryngeal lesions (time frame: 7_10 days post_intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198634, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.