Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration

Terminated

• Conditions: Trauma

• Registration Number: NCT00891085
• Lead Sponsor: University of New Mexico

Brief Summary

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

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 Timeline

• Study Start: 2007-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in ventilator days	4 years

Secondary Outcome Measures

Name	Time	Method
Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS)	4 years

Trial Locations

Locations (1)

University of New Mexico Hospital; 🇺🇸 Albuquerque, New Mexico, United States