Flow-synchronized Nasal IMV in Preterm Infants

Not Applicable

Completed

• Conditions: Respiratory Insufficiency; Premature Infant Disease
• Interventions: Other: non-synchronized NIMV; Other: Synchronized NIMV

• Registration Number: NCT02085499
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-13
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NIMV followed by S-NIMV	Synchronized NIMV	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.
S-NIMV followed by NIMV	Synchronized NIMV	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.
NIMV followed by S-NIMV	non-synchronized NIMV	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.
S-NIMV followed by NIMV	non-synchronized NIMV	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.

Primary Outcome Measures

Name	Time	Method
Ttidal volume (VT)	4 hours	Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Minute Ventilation	4 hours	Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

Secondary Outcome Measures

Name	Time	Method
Arterial oxygen saturation	4 hours	Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
fraction of inspired oxygen	4 hours	Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
transcutaneous carbon dioxide tension	4 hours	Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

Trial Locations

Locations (1)

Holtz Childrens Hospital-Jackson Health System-University of Miami; 🇺🇸 Miami, Florida, United States