Skip to main content
Clinical Trials/NCT06212037
NCT06212037RecruitingNot Applicable

POCUS of the Pediatric Critical Airway, A Prospective Clinical Observational Study

Northwell Health1 site in 1 country150 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor

Study Overview

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.

Detailed Description

The pediatric airway is markedly different front that of the adult airway, with unique anatomical challenges that can make endotracheal extubation of the pediatric airway more complicated. Pediatric patients are sensitive to small changes in diameter and patients who have been intubated may experience laryngeal edema. This laryngeal edema is multifactorial, but in large part is caused by mechanical pressure or irritation from the endotracheal tube itself. Mucosal ulcerations and laryngeal edema occur in almost all patients intubated for greater than four days. In pediatrics, the laryngeal edema from endotracheal intubation can lead to upper airway obstruction (UOA) with the development of post extubation stridor (PES), and often, respiratory distress. Early identification of patients who are at high risk for PES is critical, as it allows for proper preparation and prevention of complications.

The rates of PES have been estimated between 5% and 54%, widely varied in the literature. Some factors that have been identified as predictive of PES include young age, female gender, previous history of airway difficulties, longer intubation duration, elevated cuff pressure, incorrect endotracheal tube size, airway infection, traumatic intubation, repeated intubation attempts, prolonged intubation, aggressive tracheal aspiration, increased tube mobility, and unintentional extubations.

Recently, ultrasound has been used to help predict those patients who may be at risk for PES. Currently, cuff leak tests have been widely used to predict upper airway patency and are currently standard of care in Pediatric Intensive Care Units across the country, however, the positive predictive value of this test has consistently shown to be low. With ultrasound, a measurement of the laryngeal air column width can be used to predict patients who will develop PES. An observational study done in 2018 at a single, tertiary pediatric hospital showed that laryngeal ultrasound done by experienced ultrasonographers and radiologists prior to extubation could predict patients who would develop PES.

In critical care, there is a significant need to decrease PES rates and POCUS could provide a rapid, reliable, and sensitive assessment of the pediatric patient who is at risk for PES and its complications.

The investigators hypothesize that patients with smaller laryngeal air column width differences on POCUS will have a higher likelihood of developing PES.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Day to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Laryngeal Air Column Width Difference Measurement in Patients Who Develop Post-Extubation Stridor

Time Frame: 6 hours following extubation

The laryngeal air column width difference (LACWD) will be measured on patients prior to extubation and this measurement will be used to predict the likelihood of development of post-extubation stridor (PES, a physiological outcome measure). PES will be determined by the presence or absence of a high-pitched inspiratory sound heard by the evaluating physician or by the administration of inhaled racemic epinephrine within 0-6 hours of extubation. This information will be documented by the extubating physician (not a part of the study team) in the electronic medical record. There will not be repeated measures, the presence or absence of stridor in the six hours following extubation will be captured as a categorical value (yes or no).

Secondary Outcomes

  • Number of Patients Who Develop PES with Cuff Pressures Greater than 20cm H20 and Relationship to LACWD(6 hours following extubation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

POCUS of the Pediatric Critical Airway | Clinical Trial