Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

Not Applicable

Completed

Conditions: Episodic Hypoxemia in Mechanically Ventilated Preterm Infants

Registration Number: NCT01727505

Lead Sponsor: University of Miami

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Born at less than 32 weeks of gestational age.
Requiring mechanical ventilation on a mandatory ventilator rate greater than or equal to 20 per minute and receiving a mean tidal volume of at least 4 ml/kg.
Presenting with 4 or more episodes of hypoxemia, defined as oxygen saturation less than 75%, in the 8 hours prior to the study.

Exclusion Criteria

Major congenital anomalies.
Hemodynamic instability requiring inotropes within 72 hours prior to the study
Culture proven sepsis within 72 hours prior to the study.
Diagnosis of pulmonary interstitial emphysema or pneumothorax within the 72 hours prior to the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Time Spent With Arterial Oxygen Saturation < 75%	24 hours	Percentage of time spent with arterial oxygen saturation \< 75%

Secondary Outcome Measures

Name	Time	Method
Frequency of Severe Hypoxemia Episodes	24 hours	Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 \< 75% lasting for at least 20 seconds.
Frequency of Hypoxemia Episodes	24 hours	Frequency of hypoxemia episodes defined as episodes with arterial saturation \< 85% for at least 20 seconds
Duration of Hypoxemia Episodes	24 hours	Duration of hypoxemia episodes of arterial saturation \< 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.