Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 1 month
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Alabama
Univerisity of Alabama
RECRUITING
Birmingham
Contact Information
Primary
Kulsajan S Bhatia, MD
ksbhatia@uabmc.edu
9172149882
Backup
Colm P Travers, MD
cptravers@uabmc.edu
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 24
Treatments
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
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

Similar Clinical Trials