Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- phasic esophageal pressure deflection
Study Overview
Brief Summary
The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).
Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.
Detailed Description
In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.
Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.
- •Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
- •Informed consent available.
Exclusion Criteria
- •Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.
Outcomes
Primary Outcomes
phasic esophageal pressure deflection
Time Frame: 4 hours
Secondary Outcomes
- Cerebral oxygen saturation(4 hours)
- Arterial oxygen saturation(4 hours)
Investigators
Prof. Dr. Helmut Hummler
Prof. Dr. Helmut Hummler
University of Ulm