RecruitingNot ApplicableNCT06512935

Ventilator Pressure and Optimization of Compliance and Hemodynamics

Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial


Sponsor

University of Alabama at Birmingham

Enrollment

24 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In preterm infants \< 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants. Infants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.


Eligibility

Min Age: 7 DaysMax Age: 30 Days

Plain Language Summary

Simplified for easier understanding

This study is examining how adjusting ventilator pressure settings affects lung compliance and blood flow in very premature babies recovering from a breathing condition called respiratory distress syndrome (RDS). The goal is to find the optimal ventilator settings to minimize harm to delicate infant lungs. **You may be eligible if...** - Your baby was born at less than 34 weeks of pregnancy - Your baby is between 7 days and 1 month old at the time of enrollment - Your baby is currently on a ventilator (conventional mechanical or high-frequency jet ventilation) - Your baby is recovering from respiratory distress syndrome (RDS) - You (as the legal guardian) have provided written consent **You may NOT be eligible if...** - Your baby has a blood infection (positive blood culture sepsis) - Your baby has a congenital (birth) abnormality affecting breathing - Your baby has a serious heart defect dependent on a specific blood vessel - Your baby is considered too medically unstable to participate - Your baby has significant lung scarring (BPD) with high blood pressure in the lungs - Your baby has open skin wounds on the chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIncrease in the PEEP followed by decrease in the PEEP

Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics

OTHERDecrease in the PEEP followed by increase in the PEEP

Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics


Locations(1)

Univerisity of Alabama

Birmingham, Alabama, United States

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NCT06512935


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