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NCT01727505 · ClinicalTrials.gov registry record · NA
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01727505 is a NA study that has completed, run by University of Miami. The registered enrollment target is 30 participants.
The verdict
NCT01727505, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspiratory pressure. We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by decrease in tidal volume. This is due to a reduction in respiratory system compliance and increase in airway resistance. Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration of episodes of hypoxemia when compared to conventional mechanical ventilation during routine clinical conditions and over longer periods of time. The objective of the study is to evaluate the effects of Volume Guarantee on the duration, severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants who present with frequent hypoxemia episodes in comparison to conventional ventilation over two periods of 24 hours each and under routine clinical conditions.
Interventions
- DEVICE Sequence A: Conventional-Volume Guarantee
- DEVICE Sequence B: Volume Guarantee-Conventional
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01727505
The ClinicalTrials.gov registry entry for NCT01727505 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sequence A: Conventional-Volume Guarantee is the first listed.
NCT01727505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01727505 about?
NCT01727505 is a clinical study titled "Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia". Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspirato...
What is the current status of trial NCT01727505?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-11. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01727505?
The interventions under investigation include: Sequence A: Conventional-Volume Guarantee (DEVICE), Sequence B: Volume Guarantee-Conventional (DEVICE).
Who is sponsoring clinical trial NCT01727505?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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