Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIMV followed by S-NIMV | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-synchronized NIMV | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours |
| fraction of inspired oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours |
| Chest wall distortion by Tcd/Vt ratio |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nelson Claure, MSc, PhD | University of Miami | Principal Investigator |
| Eduardo Bancalari, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holtz Childrens Hospital-Jackson Health System-University of Miami | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Synchronized NIMV | Other | 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. |
|
Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
| 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 | 4 hours |
Measurements of inspiratory chest wall distortion (Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV |
| 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 | 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 | 4 hours |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |