Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Other study identifiers
Sponsor study identifier
interventional
30
1 country
1
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 30 participants
- Study completion date
November 2015
Actual (reported)- Listed locations
- 1 countries · 1 sites
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
November 8, 2012
Actual (reported)First Posted
November 16, 2012
Actual (reported)Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Results Posted
March 1, 2017
Actual (reported)
- Last Updated
- March 1, 2017
- Status Verified
- January 2017
- Results QC Date
- January 10, 2017
- Last Update Submitted
- January 10, 2017