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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00891085
First received: April 28, 2009
Last updated: April 29, 2009
Last verified: April 2009
History of Changes

April 28, 2009
April 29, 2009
October 2007
Not Provided
Reduction in ventilator days [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00891085 on ClinicalTrials.gov Archive Site
Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration
Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult Trauma Patients with ISS>/=25
Trauma
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
198
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Jonathan L Marinaro, MD 5052726248 jmarinaro@salud.unm.edu
United States
 
NCT00891085
07-302
Yes
Jonathan Marinaro, MD; Assistant Professor, Dept of Surgery, UNMH
University of New Mexico
Not Provided
Not Provided
University of New Mexico
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP