NCT01541514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

January 17, 2012

Last Update Submit

December 2, 2014

Conditions

Mechanically Ventilated ICU Patients

Outcome Measures

Primary Outcomes (1)

  • double stacks

    ventilator waveform recording

    number per minute over 5 minutes

Secondary Outcomes (2)

  • level of sedation

    baseline

  • mode of ventilation

    30min

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult ICU patients receiving mechanical ventilation

You may qualify if:

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

You may not qualify if:

  • neurological deficits (acute or chronic) that prevent effective diaphragm activity.
  • Neuromuscular disease affecting the diaphragm
  • Neuromuscular blockade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Jesse Hall, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

March 1, 2012

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

December 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)