Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants

This study has suspended participant recruitment.
(suboptimal enrollment after 18 months.)
Sponsor:
Collaborator:
Discovery Laboratories, Inc.
Information provided by:
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT00295230
First received: February 21, 2006
Last updated: November 6, 2007
Last verified: November 2007
  Purpose

Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. To date, only one recent study has investigated the relative advantages of combining VG with different modes of synchronized mechanical ventilation in clinically stable, preterm infants that were mechanically ventilated at an average age of one month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very low birth weight infants within the first three to five days of life. Our hypothesis is that in very low birth weight infants requiring mechanical ventilation in the first three to five days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average mean airway pressure in the PSV+VG group compared to the SIMV+VG group.


Condition Intervention Phase
Respiratory Distress Syndrome
Procedure: PSV+VG mode versus SIMV+VG mode
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effects of Volume Guarantee Combined With Pressure Supported Ventilation (PSV+VG) Versus Synchronized Intermittent Mandatory Ventilation (SIMV+VG) in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Respiratory rate [ Time Frame: 6hr ]

Secondary Outcome Measures:
  • Ventilator variables [ Time Frame: 6hr ]
  • Vital signs [ Time Frame: 6hr ]

Estimated Enrollment: 16
Study Start Date: February 2006
Estimated Study Completion Date: September 2007
Intervention Details:
    Procedure: PSV+VG mode versus SIMV+VG mode
    fully assisted mechanical ventilation versus assistance on only a select number of breaths
Detailed Description:

After informed consent is obtained, each patient will be started on the study between 72 to 96 hours of age. Each infant will be assigned via block randomization to an initial ventilation mode (PSV+VG or SIMV+VG). Mechanical ventilation will be provided using the Dräeger Babylog 8000Ò. Once on study, infants will receive each ventilation mode (PSV+VG and SIMV+VG) twice, administered in alternating ninety minute blocks. Ventilator management in each mode will be standardized as follows: ventilator rate of 30 breaths per minute, volume guarantee of 4-6 cc/kg, inspiratory time of 0.3-0.35 seconds, and positive end-expiratory pressure of 5-7 cmH2O. Peak inspiratory pressure (PIP) will be set at 15-20% above the PIP needed to achieve the set tidal volume. FiO2 will be maintained to keep oxygen saturation in the range of 85-96%. The FiO2 will only be adjusted if the infant's oxygen saturation is persistently outside of the target range. End tidal carbon dioxide levels will be obtained at two times (30 minutes and 90 minutes) during each study block.

No laboratory tests will be obtained for this study. However, blood gases may be obtained by the NICU care team during the study per their daily care plan, and subsequent ventilator changes may be made by the NICU care team if necessary to correct an undesired blood gas value.

All data will be obtained using the pre-existing equipment in place to care for the patient prior to this study. This equipment includes the mechanical ventilator, endotracheal tube, cardio-respiratory monitor, and blood pressure monitor.

The key measurements during this study are ventilator variables and physiologic vital signs. Ventilator variables include respiratory rate, actual PIP, mean airway pressure, FiO2, expiratory tidal volume, minute ventilation, and actual I-time. Vital signs include heart rate, oxygen saturation, and blood pressure. Ventilator variables will be continuously downloaded from the Dräeger Babylog 8000Ò using BabyviewÒ software. Heart rate and oxygen saturation data will be downloaded from the MassimoÒ pulse oximeter. Blood pressure measurements will be documented every ten minutes if the infant has an umbilical artery catheter (UAC) or percutaneous arterial line (PAL) in place. If the infant does not have an UAC or PAL in place prior to the study, blood pressure measurements will be obtained every thirty minutes via manual blood pressure cuff.

  Eligibility

Ages Eligible for Study:   up to 120 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

premature infants weighing </= 1500 grams and needing mechanical ventilation at 72-120 hours of age.

Criteria

Inclusion Criteria:

  • Infants will be recruited based on the following criteria: weight ≤1500 grams and need for mechanical ventilation at 72 - 120 hours of age. Recruitment will continue until 16 patients have completed the study

Exclusion Criteria:

  • Exclusion criteria include significant endotracheal tube leak (>30% leak does not allow for accurate measurement of ventilator data), use of narcotic drip medication, use of paralytic medication, use of inhaled nitric oxide, fraction of inspired oxygen (FiO2) >70% at the time of enrollment, or significant congenital defects of any organ system (e.g. cardiac, respiratory, CNS).
  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: NCT00295230

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Discovery Laboratories, Inc.
Investigators
Principal Investigator: Mark Mammel, MD Children's Hospitals and Clinics of Minnesota
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00295230     History of Changes
Other Study ID Numbers: 0512098
Study First Received: February 21, 2006
Last Updated: November 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
respiratory distress syndrome
very low birth weight infant
mechanical ventilation

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 29, 2014