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Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration (SOLV)

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ClinicalTrials.gov Identifier: NCT00891085
Recruitment Status : Unknown
Verified April 2009 by University of New Mexico.
Recruitment status was:  Recruiting
First Posted : April 30, 2009
Last Update Posted : April 30, 2009
Sponsor:
Information provided by:
University of New Mexico

Study Description
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Brief Summary:
The purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to determine if one form of assisted breathing is better than another. The two forms of assisted breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU. The investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

Condition or disease
Trauma

Detailed Description:

SOLV Hypothesis:

A prospective, randomized trial directly comparing open lung ventilation (OLV) with spontaneous breathing (SB) utilizing BiVent on the Maquet Servo-I versus synchronized intermittent mechanical ventilation (SIMV) will be conducted in the trauma-surgical intensive care unit at the University Hospital (TSICU). Both OLV-SB and SIMV protocols have been designed according to lung protective strategies. The primary goal of the SOLV trial is to see determine if the early application of open lung ventilation will less ventilator days. In addition, several secondary endpoints will be evaluated. It is not anticipated that this study will be powered to show a mortality difference.


Study Design
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Study Type : Observational
Estimated Enrollment : 198 participants
Time Perspective: Prospective
Official Title: Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration
Study Start Date : October 2007
Groups and Cohorts
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Group/Cohort
Open Lung Ventilation
within 24 hours of arrival trauma patients with ISS >25 will be randomized to BiVent (APRV)
SIMV
within 24 hours of arrival trauma patients with ISS >25 will be randomized to either SIMV or BiVent


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in ventilator days [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult Trauma Patients with ISS>/=25
Criteria

Inclusion Criteria:

  • >/=18 years of age, ISS >/=25, on ventilator for more than 48 hours

Exclusion Criteria:

  • less than 18 years of age, die or come off ventilator in less than 48 hours
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891085


Contacts
Contact: Jonathan L Marinaro, MD 5052726248 jmarinaro@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Hospital Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Jonathan Marinaro         
Principal Investigator: Jonathan L Marinaro, MD         
Sponsors and Collaborators
University of New Mexico
More Information
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Responsible Party: Jonathan Marinaro, MD; Assistant Professor, Dept of Surgery, UNMH
ClinicalTrials.gov Identifier: NCT00891085     History of Changes
Other Study ID Numbers: 07-302
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: April 2009

Keywords provided by University of New Mexico:
ventilation
ards
ali
trauma
Trauma Patients with ISS > 25