Evaluating the Patient-Ventilator Synchrony During Mechanical Ventilation in Patients With Acute Lung Injury

The overall purpose to the study is to prospectively study how often patients with and without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked breaths. The investigators seek to describe the quantity of stacked breaths by continuously recording flow, volume, and pressure waveforms routinely displayed on the vent. The investigators also seek to describe how primary ICU teams manage asynchrony documenting interventions of sedation or vent manipulation and what modality is most successful.

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilated ICU Patients

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult ICU patients receiving mechanical ventilation

Description

Inclusion Criteria:

age > 18 years intubated and mechanically ventilated diagnosed with acute lung injury (ALI) or requiring mechanical ventilation for reasons other than ALI

Exclusion Criteria:

neurological deficits (acute or chronic) that prevent effective diaphragm activity.

• Neuromuscular disease affecting the diaphragm
• Neuromuscular blockade

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
double stacks	ventilator waveform recording	number per minute over 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of sedation	Richmond Agitation Sedation Score	baseline
mode of ventilation	ventilator adjustment	30min

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (ESTIMATE): March 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 11-0172