An interventional study of non-synchronized NIMV and Synchronized NIMV in Premature Infant Disease and Respiratory Insufficiency, sponsored by University of Miami. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Miami · Not applicable, Interventional, and Other
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 11 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
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Exclusion Criteria:
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.
Other: non-synchronized NIMV · Other: 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.
Other: non-synchronized NIMV · Other: Synchronized NIMV
During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute. NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO).
During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute. S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator.
Minute Ventilation
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
Time frame: 4 hours
Ttidal volume (VT)
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
Time frame: 4 hours
Arterial oxygen saturation
Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
fraction of inspired oxygen
Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
transcutaneous carbon dioxide tension
Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
Inspiratory breathing effort
Measurements of inspiratory breathing effort obtained by esophageal manometry (cmH2O) during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
Chest wall distortion by Tcd/Vt ratio
Measurements of inspiratory chest wall distortion (Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
Chest wall distortion by phase lag
Measurements of inspiratory chest wall distortion (phase lag in degrees) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
apnea frequency
Measurements of apneic respiratory pauses (#/hour) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time frame: 4 hours
Plan to share: No
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