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

Prof. Dr. Helmut Hummler

Status: Unknown

Conditions: Respiratory Distress Syndrome

Treatments: Device: S-nIMV

Study type: Interventional

Funder types: Other

Identifiers

NCT01664832

ULMN_SIMV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups, including a placebo group

S-nIMV

Experimental group

Description:

nIMV synchronized using abdominal pressure capsule sensor device

Treatment:

Device: S-nIMV

nIMV

Placebo Comparator group

Description:

non-synchronized nasal intermittent mandatory ventilation group

Treatment:

Device: S-nIMV