Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration (SOLV)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of New Mexico.
Recruitment status was: Recruiting
Information provided by:
University of New Mexico
First received: April 28, 2009
Last updated: April 29, 2009
Last verified: April 2009
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.
||Time Perspective: Prospective
||Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration
Primary Outcome Measures:
- Reduction in ventilator days [ Time Frame: 4 years ]
Secondary Outcome Measures:
- Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) [ Time Frame: 4 years ]
| Estimated Enrollment:
| Study Start Date:
Open Lung Ventilation
within 24 hours of arrival trauma patients with ISS >25 will be randomized to BiVent (APRV)
within 24 hours of arrival trauma patients with ISS >25 will be randomized to either SIMV or BiVent
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Adult Trauma Patients with ISS>/=25
- >/=18 years of age, ISS >/=25, on ventilator for more than 48 hours
- less than 18 years of age, die or come off ventilator in less than 48 hours
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00891085
|University of New Mexico Hospital
|Albuquerque, New Mexico, United States, 87131 |
|Principal Investigator: Jonathan Marinaro |
|Principal Investigator: Jonathan L Marinaro, MD |
University of New Mexico
||Jonathan Marinaro, MD; Assistant Professor, Dept of Surgery, UNMH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 28, 2009
||April 29, 2009
Keywords provided by University of New Mexico:
ClinicalTrials.gov processed this record on May 24, 2017
Trauma Patients with ISS > 25