Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration

NCT00891085 | Terminated DMC

• 1 other identifier: 07-302
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

ventilation; ards; ali; trauma; Trauma Patients with ISS > 25

Outcome Measures

Primary Outcomes (1)

• Reduction in ventilator days

  4 years

Secondary Outcomes (1)

• Progression to acute lung injury/acute respiratory distress syndrome (ALI/ARDS)

  4 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Trauma Patients with ISS\>/=25

You may qualify if:

• \>/=18 years of age, ISS \>/=25, on ventilator for more than 48 hours

You may not qualify if:

• less than 18 years of age, die or come off ventilator in less than 48 hours

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Respiratory Aspiration; Acute Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 19, 2023

Record last verified: 2009-04

Locations

US (1)