Evaluating the Patient-Ventilator Synchrony During Mechanical Ventilation in Patients With Acute Lung Injury
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| First Received Date ICMJE | January 17, 2012 | ||||||||
| Last Updated Date | January 16, 2013 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
double stacks [ Time Frame: number per minute over 5 minutes ] [ Designated as safety issue: No ] ventilator waveform recording |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01541514 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluating the Patient-Ventilator Synchrony During Mechanical Ventilation in Patients With Acute Lung Injury | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | adult ICU patients receiving mechanical ventilation |
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| Condition ICMJE | Mechanically Ventilated ICU Patients | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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.
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01541514 | ||||||||
| Other Study ID Numbers ICMJE | 11-0172 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Russell Booth Hall, University of Chicago | ||||||||
| Study Sponsor ICMJE | University of Chicago | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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