Ventilator Pressure and Optimization of Compliance and Hemodynamics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-30
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Increase in the PEEP followed by decrease in the PEEP

    Other intervention

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

  • Decrease in the PEEP followed by increase in the PEEP

    Other intervention

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: cardiac hemodynamics and respiratory status assessment with increasing PEEPExperimental treatment 1 intervention
Group B: cardiac hemodynamics and respiratory status assessment with decreasing PEEPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

PEEP of best compliance and best oxygenation as per EIT measurements

Time frame
During a 4 hour cross-over period on either intervention

Secondary outcomes

1

Tidal volume variation

Time frame
During a 4 hour cross-over period on either intervention
2

Oxygen saturation index

Time frame
During a 4 hour cross-over period on either intervention
3

End-expiratory lung impedance (EELI), End-inspiratory lung impedance (EILI)

Time frame
During a 4 hour cross-over period on either intervention
4

Transcutaneous carbon dioxide (TcCO2) values in response to varying PEEP levels

Time frame
During a 4 hour cross-over period on either intervention

Other outcomes

Sponsors and contacts

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