NCT06229886

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

January 9, 2024

Last Update Submit

September 24, 2024

Conditions

Tricuspid RegurgitationMechanical Ventilation Pressure HighPediatric Respiratory Diseases

Keywords

PEEPInvasive Mechanical VentilationTricuspid Regurgitant Jet VelocityPoint-of-care-ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Systolic Blood Pressure

    30 minutes

  • Diastolic Blood Pressure

    30 minutes

  • Mean Arterial Pressure

    30 Minutes

  • Heart Rate

    30 minutes

Study Arms (1)

Study Participants

EXPERIMENTAL

Application of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound.

Other: Application of positive-end-expiratory pressure

Interventions

Application of positive-end-expiratory pressureOTHER

Application of PEEP on mechanically ventilated pediatric patients. Point-of-care-ultrasound performed after each PEEP application.

Study Participants

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (11)

  • 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.

    PMID: 9310800BACKGROUND

  • 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.

    PMID: 32726279BACKGROUND

  • 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.

    PMID: 35899222BACKGROUND

  • 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.

    PMID: 15269312BACKGROUND

  • Jone PN, Ivy DD. Echocardiography in pediatric pulmonary hypertension. Front Pediatr. 2014 Nov 12;2:124. doi: 10.3389/fped.2014.00124. eCollection 2014.

    PMID: 25429362BACKGROUND

  • 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.

    PMID: 7842782BACKGROUND

  • 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.

    PMID: 30090129BACKGROUND

  • 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.

    PMID: 37031182BACKGROUND

  • 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.

    PMID: 36277259BACKGROUND

  • 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.

    PMID: 10793162BACKGROUND

  • 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.

    PMID: 34632837BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 29, 2024

Study Start

December 6, 2023

Primary Completion

April 1, 2024

Study Completion

September 21, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)