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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664832

Acronym

N_SIMV

Enrollment

Registered

2012-08-14

Start date

2012-07-31

Completion date

Unknown

Last updated

2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Premature Infants, snychronized ventilation, non-invasive ventilation, RDS

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.

Interventions

DEVICES-nIMV

Synchronization of nasal breaths to infant's own respiratory effort

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
phasic esophageal pressure deflection	4 hours

Secondary

Measure	Time frame
Cerebral oxygen saturation	4 hours
Arterial oxygen saturation	4 hours

Countries

Germany

Contacts

Primary ContactHelmut Hummle, Prof. Dr.

helmut.hummler@uniklinik-ulm.de0731-500-57168

Backup ContactLi Huang, Master

hhuangli@hotmail.com015776891592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026