Ventilator Pressure and Optimization of Compliance and Hemodynamics

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06512935
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia
  • Extreme Prematurity
  • Pulmonary Hypertension Due to Lung Diseases and Hypoxia
  • Ventilation Perfusion Mismatch
  • Ventilator Lung; Newborn

Eligibility Criteria

Sex
ALL
Age
7 Days - 30 Days
Healthy Volunteers
Not accepted

Interventions

  • Increase in the PEEP followed by decrease in the PEEP — OTHER
    Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics
  • Decrease in the PEEP followed by increase in the PEEP — OTHER
    Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Aug 2025
Primary completion
May 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: cardiac hemodynamics and respiratory status assessment with increasing PEEP
    Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP. Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT
  • Active Comparator: cardiac hemodynamics and respiratory status assessment with decreasing PEEP
    Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - decrease followed by increase in PEEP. Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT

Primary Outcome Measure

Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT [ Time Frame: During a 4 hour cross-over period on either intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univerisity of AlabamaBirminghamAlabama35233-

Find similar trials in Birmingham, AL

By research site
Univerisity of Alabama· Birmingham, AL

Related Studies