- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229886
Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients
Effect of Positive End-Expiratory Pressure on Tricuspid Regurgitant Jet Velocity in Pediatric Patients on Invasive Mechanical Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
New admissions to the PICU will be identified by screening the electronic medical record (EMR) and all intubated patients will be screened and approached for enrollment if they meet inclusion criteria. After informed consent is obtained, subjects will be assigned a unique identifying number. Data will be stored in REDCap. A master link connecting subject POCUS image will be locked in the PI's office.
- POCUS measurements: POCUS will be performed when a patient is determined to meet extubation readiness criteria as decided by the PICU clinical team. When the patient is on extubation readiness trial (ERT) settings (PEEP baseline), POCUS will be performed to assess TRJV. The PEEP will be increased to PEEP baseline+3 for 15 minutes followed by a repeat POCUS to assess TRJV. The PEEP will then be increased to PEEP baseline+5 (for a max total PEEP of 10mmHg) for 15 minutes followed by a repeat POCUS to assess TRJV. The patients will then be returned to baseline ERT (PEEP baseline) settings prior to the initial POCUS.
- Interrater reliability will be evaluated amongst trained ultrasound providers by means of performing double scans for 25% of all scans performed. Each subject included in the study will have 3 scans in total (scan at PEEP baseline, scan at PEEP baseline+3, scan at PEEP baseline+5). Since the total number of scans in this study is 90, the number of double scans performed for interrater reliability will be about 22. Each double scan will include an expert ultrasound provider, along with novice ultrasound providers, who will be collecting data for this study. The novice ultrasound provider will participate in a brief informational session of how to obtain and interpret images with the expert provider.
- Images will be stored in QPATH (our secure ultrasound-image database) and will not have any patient identifiers included. In addition, the attending of record will be contacted to determine if there are any extenuating medical or social circumstances that they believe should preclude the research team from performing the POCUS. If there are, the research team will forgo the POCUS.
- The POCUS will then be reviewed by a board certified cardiologist and measurements of the TRJV will be obtained. The cardiologist will be blinded to the patient.
- Information will be obtained from the EMR as outlined in our data collection sheet.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iris Mandell, MD
- Phone Number: 718-470-3350
- Email: imandell@northwell.edu
Study Contact Backup
- Name: Chantal Talmor, MD
- Phone Number: 718-470-3350
- Email: ctalmor@northwell.edu
Study Locations
-
-
New York
-
New Hyde Park, New York, United States, 11040
- Recruiting
- Cohen Children's Medical Center
-
Contact:
- Iris Mandell, MD
- Phone Number: 718-470-3350
- Email: imandell@northwell.edu
-
Contact:
- Chantal Talmor, MD
- Phone Number: 718-470-3350
- Email: ctalmor@northwell.edu
-
Sub-Investigator:
- Kristina Murphy, DO
-
Sub-Investigator:
- Chantal Talmor, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Participants
Application of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound.
|
Application of PEEP on mechanically ventilated pediatric patients.
Point-of-care-ultrasound performed after each PEEP application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tricuspid Regurgitant Jet Velocity
Time Frame: 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: 30 minutes
|
mmHg
|
30 minutes
|
Diastolic Blood Pressure
Time Frame: 30 minutes
|
mmHg
|
30 minutes
|
Mean Arterial Pressure
Time Frame: 30 Minutes
|
mmHg
|
30 Minutes
|
Heart Rate
Time Frame: 30 minutes
|
BPM (beats per minute)
|
30 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jone PN, Ivy DD. Echocardiography in pediatric pulmonary hypertension. Front Pediatr. 2014 Nov 12;2:124. doi: 10.3389/fped.2014.00124. eCollection 2014.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-0615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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