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Study Participants for Tricuspid Regurgitation

N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients admitted to CCMC PICU who are age 3 months - 18 years old who are invasively mechanically ventilated (oral or nasotracheally)
Patients with normally functioning heart
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study Summary

This trial is a study conducted in the Pediatric Intensive Care Unit (PICU) to observe children on mechanical ventilation. The study will use a type of ultrasound called POCUS to measure the flow of

Who is the study for?
This trial is for pediatric patients in the PICU who are mechanically ventilated and nearing readiness for extubation. They must have tricuspid regurgitation, a heart condition where blood flows backward into the right upper heart chamber when it should move out to the lungs.Check my eligibility
What is being tested?
The study observes how different levels of PEEP (positive-end-expiratory pressure) affect TRJV (tricuspid regurgitant jet velocity) in children on mechanical ventilation. It's an observational study using point-of-care ultrasound during a PEEP titration protocol.See study design
What are the potential side effects?
Since this is an observational study focusing on varying levels of PEEP, direct side effects from interventions may not be applicable. However, changes in PEEP can potentially affect blood pressure and oxygenation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 months and 18 years old and on a breathing machine.
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My heart functions normally.
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My heart is structurally normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tricuspid Regurgitant Jet Velocity
Secondary outcome measures
Diastolic Blood Pressure
Heart Rate
Mean Arterial Pressure
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ParticipantsExperimental Treatment1 Intervention
Application of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
460 Previous Clinical Trials
471,013 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this study?

"Indeed, as per clinicaltrials.gov, this investigation is actively seeking individuals to participate. The trial's initial posting date was December 6th, 2023 and the most recent update occurred on January 26th, 2024."

Answered by AI

Do I meet the necessary criteria to be considered as a potential candidate for involvement in this medical study?

"To be eligible for enrollment in this clinical trial, participants must have a diagnosis of tricuspid regurgitation and fall within the age range of 3 months to 18 years. The study aims to recruit a total of 30 individuals with these criteria."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, as per the information provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking suitable candidates. The trial was initially posted on December 6th, 2023 and recently updated on January 26th, 2024. A total of 30 participants will be enrolled from a single designated site."

Answered by AI

Are individuals who are above the age of 35 eligible to participate in this study?

"According to the eligibility criteria of this trial, individuals between 3 months and 18 years old are eligible for participation."

Answered by AI
~20 spots leftby May 2025