Episodic Hypoxemia in Mechanically Ventilated Preterm Infants. Clinical Trial
Official title:
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 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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The mean and variability in FiO2 recorded data during each of the 24 hour periods. This will include Fraction of inspired oxygen | The mean and variability in in the fraction of inspired oxygen (FiO2).This will include the hourly-mean FiO2. | 24 hours | No |
| Other | Tidal volume | The mean and variability in tidal volume (VT) will be calculated. This will include the proportion of mechanical breaths with VT < 3 and < 1.5 ml/Kg. | 24 hours | No |
| Other | Minute ventilation | The mean and variability in total, mechanical and spontaneous minute ventilation will be calculated. | 24 hours | No |
| Primary | Proportion of time spent with arterial oxygen saturation < 75% | Proportion of time spent with arterial oxygen saturation < 75% | 24 hours | No |
| Secondary | hypoxemia episodes | Number, frequency, mean duration and severity of hypoxemia episodes. Hypoxemic episodes will be defined as periods with arterial oxygen saturation SpO2) < 88% and < 75%. | 24 hours | No |