Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants
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|ClinicalTrials.gov Identifier: NCT00295230|
Recruitment Status : Suspended (suboptimal enrollment after 18 months.)
First Posted : February 23, 2006
Last Update Posted : November 7, 2007
|Condition or disease||Intervention/treatment|
|Respiratory Distress Syndrome||Procedure: PSV+VG mode versus SIMV+VG mode|
After informed consent is obtained, each patient will be started on the study between 72 to 96 hours of age. Each infant will be assigned via block randomization to an initial ventilation mode (PSV+VG or SIMV+VG). Mechanical ventilation will be provided using the Dräeger Babylog 8000Ò. Once on study, infants will receive each ventilation mode (PSV+VG and SIMV+VG) twice, administered in alternating ninety minute blocks. Ventilator management in each mode will be standardized as follows: ventilator rate of 30 breaths per minute, volume guarantee of 4-6 cc/kg, inspiratory time of 0.3-0.35 seconds, and positive end-expiratory pressure of 5-7 cmH2O. Peak inspiratory pressure (PIP) will be set at 15-20% above the PIP needed to achieve the set tidal volume. FiO2 will be maintained to keep oxygen saturation in the range of 85-96%. The FiO2 will only be adjusted if the infant's oxygen saturation is persistently outside of the target range. End tidal carbon dioxide levels will be obtained at two times (30 minutes and 90 minutes) during each study block.
No laboratory tests will be obtained for this study. However, blood gases may be obtained by the NICU care team during the study per their daily care plan, and subsequent ventilator changes may be made by the NICU care team if necessary to correct an undesired blood gas value.
All data will be obtained using the pre-existing equipment in place to care for the patient prior to this study. This equipment includes the mechanical ventilator, endotracheal tube, cardio-respiratory monitor, and blood pressure monitor.
The key measurements during this study are ventilator variables and physiologic vital signs. Ventilator variables include respiratory rate, actual PIP, mean airway pressure, FiO2, expiratory tidal volume, minute ventilation, and actual I-time. Vital signs include heart rate, oxygen saturation, and blood pressure. Ventilator variables will be continuously downloaded from the Dräeger Babylog 8000Ò using BabyviewÒ software. Heart rate and oxygen saturation data will be downloaded from the MassimoÒ pulse oximeter. Blood pressure measurements will be documented every ten minutes if the infant has an umbilical artery catheter (UAC) or percutaneous arterial line (PAL) in place. If the infant does not have an UAC or PAL in place prior to the study, blood pressure measurements will be obtained every thirty minutes via manual blood pressure cuff.
|Study Type :||Observational|
|Estimated Enrollment :||16 participants|
|Official Title:||The Effects of Volume Guarantee Combined With Pressure Supported Ventilation (PSV+VG) Versus Synchronized Intermittent Mandatory Ventilation (SIMV+VG) in Very Low Birth Weight Infants|
|Study Start Date :||February 2006|
|Estimated Study Completion Date :||September 2007|
Procedure: PSV+VG mode versus SIMV+VG mode
- Respiratory rate [ Time Frame: 6hr ]
- Ventilator variables [ Time Frame: 6hr ]
- Vital signs [ Time Frame: 6hr ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295230
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Mark Mammel, MD||Children's Hospitals and Clinics of Minnesota|