Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation Pressure High; Tricuspid Regurgitation; Pediatric Respiratory Diseases
• Interventions: Other: Application of positive-end-expiratory pressure

• Registration Number: NCT06229886
• Lead Sponsor: Northwell Health

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.

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. Information will be obtained from the EMR as outlined in our data collection sheet.

Study Timeline

• Study Start: 2023-12-06
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-04-01
• Study Completion: 2024-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	Application of positive-end-expiratory pressure	Application of positive-end-expiratory-pressure on mechanically ventilated patients while performing point-of-care-ultrasound.

Primary Outcome Measures

Name	Time	Method
Tricuspid Regurgitant Jet Velocity	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).

Secondary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	30 Minutes	mmHg
Heart Rate	30 minutes	BPM (beats per minute)
Diastolic Blood Pressure	30 minutes	mmHg
Systolic Blood Pressure	30 minutes	mmHg

Trial Locations

Locations (1)

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States