Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Nelson Claure, University of Miami
ClinicalTrials.gov Identifier:
NCT01727505
First received: November 8, 2012
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Episodic Hypoxemia in Mechanically Ventilated Preterm Infants.
Device: volume guarantee ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Proportion of time spent with arterial oxygen saturation < 75% [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Proportion of time spent with arterial oxygen saturation < 75%


Secondary Outcome Measures:
  • hypoxemia episodes [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number, frequency, mean duration and severity of hypoxemia episodes. Hypoxemic episodes will be defined as periods with arterial oxygen saturation SpO2) < 88% and < 75%.


Other Outcome Measures:
  • The mean and variability in FiO2 recorded data during each of the 24 hour periods. This will include Fraction of inspired oxygen [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The mean and variability in in the fraction of inspired oxygen (FiO2).This will include the hourly-mean FiO2.

  • Tidal volume [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Minute ventilation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The mean and variability in total, mechanical and spontaneous minute ventilation will be calculated.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional-Volume Guarantee
This study Arm will consist of a 24-hour period during which the infant receives conventional mechanical ventilation and a second 24 hour period during which the infant receives volume guarantee ventilation.
Device: volume guarantee ventilation

The study will consist of two arms. In one arm, a 24-hour period during which the infant receives conventional mechanical ventilation and a second 24 hour period during which the infant receives volume guarantee ventilation.

In the other Arm, a 24-hour period during which the infant receives volume guarantee ventilation and a second 24 hour period during which the infant receives conventional mechanical ventilation.

These two arms will be assigned at random. Both conventional and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).

During the 24 hour period of conventional ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.

During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.

Active Comparator: Volume Guarantee-Conventional
This study Arm will consist of a 24-hour period during which the infant receives volume guarantee ventilation and a second 24 hour period during which the infant receives conventional mechanical ventilation.
Device: volume guarantee ventilation

The study will consist of two arms. In one arm, a 24-hour period during which the infant receives conventional mechanical ventilation and a second 24 hour period during which the infant receives volume guarantee ventilation.

In the other Arm, a 24-hour period during which the infant receives volume guarantee ventilation and a second 24 hour period during which the infant receives conventional mechanical ventilation.

These two arms will be assigned at random. Both conventional and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).

During the 24 hour period of conventional ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.

During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727505

Contacts
Contact: Nelson Claure, M.Sc., Ph.D. 3055856408 nclaure@miami.edu
Contact: Carmen D'Ugard, M.D., R.R.T. 3055856408 cdugard@med.miami.edu

Locations
United States, Florida
Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System Recruiting
Miami, Florida, United States, 33136
Contact: Carmen D'Ugard, M.D., R.R.T.    305-585-6408    cdugard@med.miami.edu   
Principal Investigator: Nelson Claure, M.Sc., Ph.D.         
Principal Investigator: Eduardo Bancalari, M.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Nelson Claure, M.Sc., Ph.D. University of Miami
Principal Investigator: Eduardo Bancalari, M.D. University of Miami
  More Information

No publications provided

Responsible Party: Nelson Claure, Research Associate Professor of Pediatrics, University of Miami
ClinicalTrials.gov Identifier: NCT01727505     History of Changes
Other Study ID Numbers: 20120623
Study First Received: November 8, 2012
Last Updated: March 7, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Miami:
hypoxemia
desaturation
mechanical ventilation
preterm infants
volume guarantee ventilation

ClinicalTrials.gov processed this record on October 30, 2014