Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- PEEP of best compliance and best oxygenation as per EIT measurements
Study Overview
Brief 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.
Detailed Description
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 EIT to optimize ventilator settings in preterm infants.
Neonatal ventilation is a critical intervention to support breathing for newborns with respiratory distress syndrome (RDS), underdeveloped lungs, and evolving bronchopulmonary dysplasia (BPD). Positive airway pressure helps maintain patency of the airways and improves ventilation and oxygenation by maintaining the functional residual capacity (FRC) and keeping the alveoli patent. Peak inspiratory pressure (PIP) and positive end-expiratory pressure (PEEP) are terms commonly used in mechanical ventilation to describe the pressures applied to the respiratory system during the different phases of the breathing cycle. These parameters are essential in managing and optimizing ventilation for infants with respiratory failure.
This study will include preterm infants with recovering RDS born at age < 34 weeks of gestational age on respiratory support via conventional mechanical ventilation or on high-frequency jet ventilation (HFJV). Infants will be randomized to the order of testing, increasing the PEEP (+1 cmH2O and +2 cmH2O) or decreasing the PEEP (+1 cmH2O and +2 cmH2O) with baseline measurements and Echo done at original PEEP and each subsequent PEEP.
Following informed consent, randomization will be performed using sequentially numbered sealed opaque envelopes. The randomization envelope will be signed before it is opened just before starting the study on each infant to indicate the first intervention for the infant.
This will be a single-center, randomized crossover study. The randomization envelope will be signed before it is opened just before starting the study on each infant to indicate the first intervention for the infant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Days to 30 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
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
Intervention: Increase in the PEEP followed by decrease in the PEEP (Other)
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
Intervention: Decrease in the PEEP followed by increase in the PEEP (Other)
Outcomes
Primary Outcomes
PEEP of best compliance and best oxygenation as per EIT measurements
Time Frame: During a 4 hour cross-over period on either intervention
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
Secondary Outcomes
- Oxygen saturation index(During a 4 hour cross-over period on either intervention)
- Tidal volume variation(During a 4 hour cross-over period on either intervention)
- Respiratory Severity Score (RSS)(During a 4 hour cross-over period on either intervention)
- End-expiratory lung impedance (EELI), End-inspiratory lung impedance (EILI)(During a 4 hour cross-over period on either intervention)
- Transcutaneous carbon dioxide (TcCO2) values in response to varying PEEP levels(During a 4 hour cross-over period on either intervention)
- % tidal distribution(During a 4 hour cross-over period on either intervention)
- oxygen saturation (SpO2) values(During a 4 hour cross-over period on either intervention)
Investigators
Kulsajan Singh Bhatia
Neonatal Perinatal Fellow
University of Alabama at Birmingham