Tricuspid Regurgitation Clinical Trial
Official title:
Effect of Positive End-Expiratory Pressure on Tricuspid Regurgitant Jet Velocity in Pediatric Patients on Invasive Mechanical Ventilation
Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV) children. Mechanically ventilated (MV) children approaching extubation as per the discretion of the PICU clinical team will undergo a positive end expiratory pressure (PEEP) titration protocol in a safe and timely manner in the PICU. During this PEEP titration, POCUS will be performed by a pediatric intensivist and interpreted by a pediatric cardiologist. Medical demographics will be collected from the electronic medical record and recorded.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 11, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 18 Years |
Eligibility | Inclusion Criteria: - Patients admitted to Cohen Children's Medical Center (CCMC) PICU who are age 3 months - 18 years old who are invasively mechanically ventilated (oral or nasotracheally). - Patients on or approaching extubation readiness trial. - Patients with structurally normal heart. - Patients with normally functioning heart. - Consent by a legal guardian. Exclusion Criteria: - Patients with known air-leak syndrome. - Patients with history of congenital heart disease (CHD) (pre/post repair). - Patients with significant cardiac dysfunction and/or on vasoactive medications. - Patients with history of cardiomyopathy. - Patients with history of pulmonary hypertension. - Patients with history of chronic respiratory failure. - Patients with known mediastinal mass. - Patients with tracheostomy. |
Country | Name | City | State |
---|---|---|---|
United States | Cohen Children's Medical Center | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. — View Citation
Artucio H, Hurtado J, Zimet L, de Paula J, Beron M. PEEP-induced tricuspid regurgitation. Intensive Care Med. 1997 Aug;23(8):836-40. doi: 10.1007/s001340050419. — View Citation
Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Pare JR. Tricuspid Regurgitant Jet Velocity Point-of-Care Ultrasound Curriculum Development and Validation. POCUS J. 2021 Nov 23;6(2):88-92. doi: 10.24908/pocus.v6i2.15190. — View Citation
Binder ZW, O'Brien SE, Boyle TP, Cabral HJ, Sekhavat S, Pare JR. Novice Physician Ultrasound Evaluation of Pediatric Tricuspid Regurgitant Jet Velocity. West J Emerg Med. 2020 Jun 24;21(4):1029-1035. doi: 10.5811/westjem.2020.3.45882. — View Citation
Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327-36. doi: 10.1056/NEJMoa032193. — View Citation
Jone PN, Ivy DD. Echocardiography in pediatric pulmonary hypertension. Front Pediatr. 2014 Nov 12;2:124. doi: 10.3389/fped.2014.00124. eCollection 2014. — View Citation
Jullien T, Valtier B, Hongnat JM, Dubourg O, Bourdarias JP, Jardin F. Incidence of tricuspid regurgitation and vena caval backward flow in mechanically ventilated patients. A color Doppler and contrast echocardiographic study. Chest. 1995 Feb;107(2):488-93. doi: 10.1378/chest.107.2.488. — View Citation
Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17. — View Citation
Lai C, Shi R, Beurton A, Moretto F, Ayed S, Fage N, Gavelli F, Pavot A, Dres M, Teboul JL, Monnet X. The increase in cardiac output induced by a decrease in positive end-expiratory pressure reliably detects volume responsiveness: the PEEP-test study. Crit Care. 2023 Apr 9;27(1):136. doi: 10.1186/s13054-023-04424-7. — View Citation
Persson JN, Kim JS, Good RJ. Diagnostic Utility of Point-of-Care Ultrasound in the Pediatric Cardiac Intensive Care Unit. Curr Treat Options Pediatr. 2022;8(3):151-173. doi: 10.1007/s40746-022-00250-1. Epub 2022 Jul 8. — View Citation
Watkins LA, Dial SP, Koenig SJ, Kurepa DN, Mayo PH. The Utility of Point-of-Care Ultrasound in the Pediatric Intensive Care Unit. J Intensive Care Med. 2022 Aug;37(8):1029-1036. doi: 10.1177/08850666211047824. Epub 2021 Oct 9. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tricuspid Regurgitant Jet Velocity | The primary endpoint for the study will be TRJV at baseline PEEP (PEEP baseline) and subsequent PEEP increments (PEEP baseline+3, PEEP baseline+5). | 30 minutes | |
Secondary | Systolic Blood Pressure | mmHg | 30 minutes | |
Secondary | Diastolic Blood Pressure | mmHg | 30 minutes | |
Secondary | Mean Arterial Pressure | mmHg | 30 Minutes | |
Secondary | Heart Rate | BPM (beats per minute) | 30 minutes |
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