Flow-synchronized Nasal IMV in Preterm Infants

University of Miami

Status: Completed

Conditions: Respiratory Insufficiency; Premature Infant Disease

Treatments: Other: non-synchronized NIMV; Other: Synchronized NIMV

Study type: Interventional

Funder types: Other

Identifiers

NCT02085499

20130844

Details and patient eligibility

About

The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.

The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.

The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.

This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.

The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.

The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants of 30 or less weeks of gestational age
• Receiving NIMV
• Requiring Fi02 > 0.21 to keep Sp02 > 90%
• Parental written informed consent

Exclusion criteria

• Major congenital anomalies
• Proven sepsis within 72 hours of the study
• Hypotension requiring pressors within 72 hours of the study
• Pneumothorax or pneumomediastinum within 72 hours of the study
• Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

NIMV followed by S-NIMV

Other group

Description:

During the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV.

Treatment:

Other: non-synchronized NIMV

Other: Synchronized NIMV

S-NIMV followed by NIMV

Other group

Description:

During the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV.

Treatment:

Other: non-synchronized NIMV

Other: Synchronized NIMV