Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Synchronized Intermittent Mechanical Ventilation vs Open Lung Ventilation With Spontaneous Respiration

Conditions
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Trauma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Lung Ventilation<br>within 24 hours of arrival trauma patients with ISS >25 will be randomized to BiVent (APRV) | |
| SIMV<br>within 24 hours of arrival trauma patients with ISS >25 will be randomized to either SIMV or BiVent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in ventilator days |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS) |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventilation, ards, ali, trauma, Trauma Patients with ISS > 25