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

November 6, 2007 updated by: Children's Hospitals and Clinics of Minnesota

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory rate
Time Frame: 6hr
6hr

Secondary Outcome Measures

Outcome Measure
Time Frame
Ventilator variables
Time Frame: 6hr
6hr
Vital signs
Time Frame: 6hr
6hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Collaborators

Windtree Therapeutics

Investigators

  • Principal Investigator: Mark Mammel, MD, Children's Hospitals and Clinics of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

September 1, 2007

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 23, 2006

Study Record Updates

Last Update Posted (Estimate)

November 7, 2007

Last Update Submitted That Met QC Criteria

November 6, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0512098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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