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

Inclusion Criteria4

  • Preterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \< 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.
  • Post-natal age \> 7 days and less than 1 month (outside golden week protocol)
  • Gestational age ≥ 21 weeks and ≤ 34 week
  • Infants with written informed consent obtained from legal guardian

Exclusion Criteria7

  • Blood culture-positive sepsis
  • Congenital anomalies affecting respiration
  • Cyanotic or ductal-dependent congenital heart disease
  • Newborns who are considered too unstable for study enrolment per neonatology attending
  • Newborns on pressors or steroids for maintaining cardiac output
  • Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)
  • Open skin wounds or abrasions on the chest wall.

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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