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

Mechanically Ventilated ICU Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541514
• Other study ID #: 11-0172
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: December 2, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mechanically Ventilated ICU Patients

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	double stacks	ventilator waveform recording	number per minute over 5 minutes	No
Secondary	level of sedation	Richmond Agitation Sedation Score	baseline	No
Secondary	mode of ventilation	ventilator adjustment	30min	No