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

Respiratory Distress Syndrome Clinical Trial

— N_SIMV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01664832
• Other study ID #: ULMN_SIMV
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2012
• Last updated: June 26, 2013
• Start date: July 2012

Study information

• Verified date: June 2013
• Source: University of Ulm
• Contact: Helmut Hummle, Prof. Dr.
• Phone: 0731-500-57168
• Email: helmut.hummler[@]uniklinik-ulm.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort

Locations

Country	Name	City	State
Germany	Children's Hospital University of Ulm	Ulm	Baden-Wüttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Helmut Hummler

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phasic esophageal pressure deflection		4 hours	No
Secondary	Cerebral oxygen saturation		4 hours	No
Secondary	Arterial oxygen saturation		4 hours	No