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

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ClinicalTrials.gov Identifier: NCT01541514
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease
Mechanically Ventilated ICU Patients

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : December 2013

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Primary Outcome Measures :
  1. double stacks [ Time Frame: number per minute over 5 minutes ]
    ventilator waveform recording


Secondary Outcome Measures :
  1. level of sedation [ Time Frame: baseline ]
    Richmond Agitation Sedation Score

  2. mode of ventilation [ Time Frame: 30min ]
    ventilator adjustment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult ICU patients receiving mechanical ventilation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541514


Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jesse Hall, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01541514     History of Changes
Other Study ID Numbers: 11-0172
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014