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
  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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Reduction in ventilator days [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Adult Trauma Patients with ISS>/=25

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891085

Contacts
Contact: Jonathan L Marinaro, MD 5052726248 jmarinaro@salud.unm.edu

Locations
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         
Sponsors and Collaborators
University of New Mexico
  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 September 18, 2014