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
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Condition or disease |
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Trauma |
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 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 |

Group/Cohort |
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Open Lung Ventilation
within 24 hours of arrival trauma patients with ISS >25 will be randomized to BiVent (APRV)
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SIMV
within 24 hours of arrival trauma patients with ISS >25 will be randomized to either SIMV or BiVent
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- Reduction in ventilator days [ Time Frame: 4 years ]
- Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) [ Time Frame: 4 years ]

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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 |
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

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
Contact: Jonathan L Marinaro, MD | 5052726248 | jmarinaro@salud.unm.edu |
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 |
Responsible Party: | Jonathan Marinaro, MD; Assistant Professor, Dept of Surgery, UNMH |
ClinicalTrials.gov Identifier: | NCT00891085 |
Other Study ID Numbers: |
07-302 |
First Posted: | April 30, 2009 Key Record Dates |
Last Update Posted: | April 30, 2009 |
Last Verified: | April 2009 |
ventilation ards ali trauma Trauma Patients with ISS > 25 |
Wounds and Injuries |