Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
150 participants
OBSERVATIONAL
2023-12-01
2025-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection
NCT06425107
Diagnostic Role of Chest Ultrasound in Children Presenting With Respiratory Distress in Pediatric Intensive Care Unit (PICU) Compared to Chest X-ray
NCT04328220
Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit
NCT03505814
Air Leak Test In Pediatric Intensive Care Unit
NCT05328206
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
NCT02321956
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Ultrasound measurements will be completed as soon as the patient is deemed to perform extubation readiness assessments, as determined by the attending pediatric intensivist. The ultrasound will be performed within 1 to 12 hours prior to extubation, alongside the Respiratory Therapist evaluation of cuff pressure, per standard unit protocol.
A high frequency linear phased array probe will be used for obtaining the images with a General Electric (GE) ultrasound machine. Prior to obtaining images, the endotracheal tube will be suctioned per unit standard nursing protocol. Additionally, oral and pharyngeal secretions will be gently suctioned. The linear probe will then be placed on the cricothyroid membrane with a transverse view of the larynx. The scanning plane will contain multiple landmarks, including the vocal cords, the tracheal cartilage, and possibly, the arytenoid cartilages. The laryngeal air column width will then be measured with the endotracheal tube cuff inflated and deflated. The laryngeal air column width difference is the difference between the balloon inflated width minus the balloon deflated width.
Three measurements of the laryngeal air column width difference will be taken and averaged for a final value. The presence of PES will be defined by the administration of racemic epinephrine within 6 hours of extubation, as detemined by the extubating physician, who is not a part of the study team.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mechanical ventilation with an endotracheal tube
* Patient on or approaching extubation readiness
Exclusion Criteria
* 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
1 Day
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwell Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristina Murphy, DO
Role: PRINCIPAL_INVESTIGATOR
Northwell Health, Cohen Children's Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cohen Children's Medical Center
Queens, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-0649
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.