Ventilator Pressure and Optimization of Compliance and Hemodynamics

NCT06512935 | Recruiting DMC

• 1 other identifier: IRB-300013132
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Respiratory distress syndrome; ventilation mechanics in newborn; cardiac hemodynamics newborn

Outcome Measures

Primary Outcomes (2)

• Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT

  During a 4 hour cross-over period on either intervention

• PEEP of best compliance and best oxygenation as per EIT measurements

  During a 4 hour cross-over period on either intervention

Secondary Outcomes (7)

• Tidal volume variation

  During a 4 hour cross-over period on either intervention

• Oxygen saturation index

  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

• Respiratory Severity Score (RSS)

  During a 4 hour cross-over period on either intervention

Study Arms (2)

cardiac hemodynamics and respiratory status assessment with increasing PEEP

EXPERIMENTAL

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

Other: Increase in the PEEP followed by decrease in the PEEP

cardiac hemodynamics and respiratory status assessment with decreasing PEEP

ACTIVE COMPARATOR

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

Other: Decrease in the PEEP followed by increase in the PEEP

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

cardiac hemodynamics and respiratory status assessment with increasing PEEP

Decrease in the PEEP followed by increase in the PEEP OTHER

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

cardiac hemodynamics and respiratory status assessment with decreasing PEEP

Eligibility Criteria

• Age: 7 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Univerisity of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Hypoxia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Kulsajan S Bhatia, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Colm P Travers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kulsajan S Bhatia, MD

CONTACT

9172149882; ksbhatia@uabmc.edu

Colm P Travers, MD

CONTACT

cptravers@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatal Perinatal Fellow

Model Details: Single centre, randomized crossover study. 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 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 at each subsequent PEEP.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)