Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: S-nIMV


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-nIMV<br>nIMV synchronized using abdominal pressure capsule sensor device | Device: S-nIMV<br>* Synchronization of nasal breaths to infant's own respiratory effort<br>|
| Placebo Comparator: nIMV<br>non-synchronized nasal intermittent mandatory ventilation group | Device: S-nIMV<br>* Synchronization of nasal breaths to infant's own respiratory effort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phasic esophageal pressure deflection |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen saturation |  | 4 hours | 
| Arterial oxygen saturation |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infants, snychronized ventilation, non-invasive ventilation, RDS