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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01541514
First received: January 17, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Mechanically Ventilated ICU Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • double stacks [ Time Frame: number per minute over 5 minutes ] [ Designated as safety issue: No ]
    ventilator waveform recording


Secondary Outcome Measures:
  • level of sedation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Richmond Agitation Sedation Score

  • mode of ventilation [ Time Frame: 30min ] [ Designated as safety issue: No ]
    ventilator adjustment


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  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 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
  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: NCT01541514

Contacts
Contact: Anne Pohlman, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu
Contact: Jesse Hall, MD 773-702-1454 jhall@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne Pohlman, MSN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Principal Investigator: Jesse Hall, MD         
Sub-Investigator: Shruti Patel, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jesse Hall, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01541514     History of Changes
Other Study ID Numbers: 11-0172
Study First Received: January 17, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014