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

Not Applicable

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: S-nIMV

• Registration Number: NCT01664832
• Lead Sponsor: Prof. Dr. Helmut Hummler

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-14
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27
• Primary Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nIMV	S-nIMV	non-synchronized nasal intermittent mandatory ventilation group
S-nIMV	S-nIMV	nIMV synchronized using abdominal pressure capsule sensor device

Primary Outcome Measures

Name	Time	Method
phasic esophageal pressure deflection	4 hours

Secondary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation	4 hours
Arterial oxygen saturation	4 hours

Trial Locations

Locations (1)

Children's Hospital University of Ulm; 🇩🇪 Ulm, Baden-Wüttemberg, Germany