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CompletedNCT01541514Updated Dec 3, 2014

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

An observational study in Mechanically Ventilated ICU Patients, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by University of Chicago · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mechanically Ventilated ICU Patients
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult ICU patients receiving mechanical ventilation

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

Exclusion Criteria:

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

  • Neuromuscular disease affecting the diaphragm
  • Neuromuscular blockade
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
06

What researchers measure

Primary outcomes

  1. double stacks

    ventilator waveform recording

    Time frame: number per minute over 5 minutes

Secondary outcomes

  1. level of sedation

    Richmond Agitation Sedation Score

    Time frame: baseline

  2. mode of ventilation

    ventilator adjustment

    Time frame: 30min

07

Study locations

1 site
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01541514
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Mar 1, 2012
Start date
Jul 2011
Primary completion
Apr 2012
Completion
Dec 2013
Last update
Dec 3, 2014

Study contacts

Jesse Hall, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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