POCUS of the Pediatric Critical Airway

NCT06212037 | Unknown

• 1 other identifier: 23-0649
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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).

  6 hours following extubation

Secondary Outcomes (1)

• Number of Patients Who Develop PES with Cuff Pressures Greater than 20cm H20 and Relationship to LACWD

  6 hours following extubation

Interventions

Point of Care Ultrasound DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Projected 150 patients. The CCMC PICU is a 37-bed regional referral center with approximately 2500 admissions annually. Recruitment can be accomplished while allowing for loss due to exclusions, timing, or non-consent. Approximately 350 children are extubated each year.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Cohen Children's Medical Center

Queens, New York, 11040, United States

RECRUITING

Related Publications (6)

• Bhargava V, Rockwell NA, Tawfik D, Haileselassie B, Petrisor C, Su E. Prediction of Difficult Laryngoscopy Using Ultrasound: A Systematic Review and Meta-Analysis. Crit Care Med. 2023 Jan 1;51(1):117-126. doi: 10.1097/CCM.0000000000005711. Epub 2022 Nov 3.

  PMID: 36519985 BACKGROUND

• Burton L, Bhargava V, Kong M. Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. Front Pediatr. 2022 Feb 1;9:830160. doi: 10.3389/fped.2021.830160. eCollection 2021.

  PMID: 35178366 BACKGROUND

• Daniel SJ, Bertolizio G, McHugh T. Airway ultrasound: Point of care in children-The time is now. Paediatr Anaesth. 2020 Mar;30(3):347-352. doi: 10.1111/pan.13823. Epub 2020 Jan 20.

  PMID: 31901216 BACKGROUND

• Kimura S, Ahn JB, Takahashi M, Kwon S, Papatheodorou S. Effectiveness of corticosteroids for post-extubation stridor and extubation failure in pediatric patients: a systematic review and meta-analysis. Ann Intensive Care. 2020 Nov 18;10(1):155. doi: 10.1186/s13613-020-00773-6.

  PMID: 33206245 BACKGROUND

• Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22.

  PMID: 12528025 BACKGROUND

• Venkategowda PM, Mahendrakar K, Rao SM, Mutkule DP, Shirodkar CG, Yogesh H. Laryngeal air column width ratio in predicting post extubation stridor. Indian J Crit Care Med. 2015 Mar;19(3):170-3. doi: 10.4103/0972-5229.152763.

  PMID: 25810614 BACKGROUND

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina Murphy, DO

  Northwell Health, Cohen Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Murphy, DO

CONTACT

516-562-1593; kmuprhy16@northwell.edu

April Slamowitz, MD

CONTACT

aslamowitz@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 18, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)