Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 9:38 AM
Study NCT ID:
NCT01049958
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients
Sponsor:
University of Cincinnati
Organization:
Study Overview
Official Title:
Prevalence of Patient Ventilator Asynchrony in Trauma and Surgical Patients
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Asynchrony
Brief Summary:
This study will examine the prevalence of patient-ventilator asynchrony and its determinants. Mechanically ventilated trauma patients often experience asynchrony when their pattern of breathing does not match the triggering of a mechanical ventilator.
Asynchrony is thought to be more common in delirious patients, patients with chronic lung disease and those who are heavily sedated. The study will examine the relationship between (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.
Asynchrony is thought to be more common in delirious patients, patients with chronic lung disease and those who are heavily sedated. The study will examine the relationship between (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.
Detailed Description:
This is a prospective observational study to determine the prevalence of patient/ventilator asynchrony in a cohort of trauma and surgical patients. There will be two 20-minute periods of observation. The first will be during the first 24 hours of mechanical ventilation and the second will take place when the patient is being weaned from the ventilator and is triggering half or more of all ventilator breaths.
The study team will use computer-captured waveforms to determine the proportion of all breaths that are asynchronous. This proportion is the primary outcome variable of the study.
The study hypothesis is that the proportion of asynchronous breaths is higher in patients with higher levels of sedation, as measured by the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Methods for the Intensive Care Unit (CAM-ICU). This hypothesis will be tested using repeated measures analysis of variance.
The study team will use computer-captured waveforms to determine the proportion of all breaths that are asynchronous. This proportion is the primary outcome variable of the study.
The study hypothesis is that the proportion of asynchronous breaths is higher in patients with higher levels of sedation, as measured by the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Methods for the Intensive Care Unit (CAM-ICU). This hypothesis will be tested using repeated measures analysis of variance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: