Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration (SOLV)
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Trauma |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration |
- Reduction in ventilator days [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 198 |
| Study Start Date: | October 2007 |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Adult Trauma Patients with ISS>/=25
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| 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 | |
More Information
No publications provided
| Responsible Party: | Jonathan Marinaro, MD; Assistant Professor, Dept of Surgery, UNMH |
| ClinicalTrials.gov Identifier: | NCT00891085 History of Changes |
| Other Study ID Numbers: | 07-302 |
| Study First Received: | April 28, 2009 |
| Last Updated: | April 29, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of New Mexico:
|
ventilation ards ali trauma Trauma Patients with ISS > 25 |
ClinicalTrials.gov processed this record on May 19, 2013