Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06212037

Conditions

Stridor

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Point of Care Ultrasound

Study Details

Brief summary:

The goal of this observational study is to assess the laryngeal air column width difference measurement on point of care ultrasound as a predictive indicator of post-extubation stridor in the pediatric critical care population.

The main question it claims to answer is: In pediatric intensive care unit patients, can point of care ultrasound measurements of laryngeal air column width difference be used as a sensitive and specific tool to predict post extubation stridor in comparison to standard qualitative and quantitative evaluations?

Participants will be enrolled when they are on or approaching extubation readiness. At this time, an ultrasound of their airway will be performed by the investigators and the laryngeal air column width difference will be recorded.

Conditions

Stridor

Study ID

NCT06212037

Start date

Dec 1, 2023

Status verified date

Jan, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 0 to 18 years
  • Mechanical ventilation with an endotracheal tube
  • Patient on or approaching extubation readiness

Exclusion Criteria:

  • Age >18 years
  • Current tracheostomy in place
  • History of recent upper airway obstruction or vocal cord paralysis
  • Patients who cannot have their neck in a slightly hyperextended position due to injury or ligament laxity

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

Point of Care Ultrasound

Point of Care Ultrasound will be performed on all subjects and their laryngeal air column width difference will be calculated. The patients will be followed after extubation and the presence/absence of post extubation stridor will be recorded.

Primary outcome measure

  • Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor [ Time Frame: 6 hours following extubation ]

Central Contacts and Locations

Central contacts

Kristina Murphy, DO

516-562-1593kmuprhy16@northwell.edu

April Slamowitz, MD

aslamowitz@northwell.edu

Locations

Cohen Children's Medical Center

Recruiting

Queens, New York, United States, 11040

Contacts

Kristina Murphy, DO

kmurphy16@northwell.edu

April Slamowitz, MD

aslamowitz@northwell.edu

Principal Investigator:

Kristina Murphy, DO

More Information

Sponsor

Northwell Health

Last update posted

Jan 18, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-01-18.