- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336464
Impact of Dyspnea on Patients in the Intensive Care Unit (DYSTRESS)
Impact of DYSpnea on the ouTcome of Patients Admitted for an Acute RESpiratory Failure in the intenSive Care Unit
Study Overview
Status
Conditions
Detailed Description
Intensive care unit (ICU) patients are continuously exposed to various unpleasant sensations that are as many sources of discomfort. If, growing attention has been given to the detection and treatment of pain, very little attention has been given to dyspnea. However, there is growing evidence suggesting that dyspnea is frequent and severe in mechanically ventilated ICU patients. In mechanically ventilated ICU patients, dyspnea is independently associated with anxiety and mechanical ventilation itself. Indeed, an optimization of ventilator settings alleviates dyspnea in 35% of patients.
Various arguments suggest that dyspnea contributes to the dark experience of ICU and participates to the genesis of post traumatic stress disorders. In addition, dyspnea is associated with a longer duration of mechanical ventilation.
Large multicentre studies are however lacking. The aims of the present multicentre study are 1) to quantify the prevalence of dyspnea in a large population of ICU mechanically ventilated patients, 2) to examine the link between the level of dyspnea and the occurrence of adverse events in the ICU, 3) to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorder associated symptoms.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75013
- Groupe Hospitalier Pitie Salpetriere
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Invasive mechanical ventilation in the ICU for > 24 hours
- Remaining stay in the ICU estimated > 24 hours
Exclusion criteria :
- RASS <-2 or >+2
- Delirium (defined according to CAM-ICU)
- Severe cognitive impairment or severe psychiatric disease
- Patient who does not understand French
- Severe depthless
- Age <18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICU length of stay
Time Frame: 3 months
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3 months
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incidence of post traumatic stress disorders
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression (Hamilton anxiety and depression scale)
Time Frame: 3 months
|
Hamilton anxiety and depression scale
|
3 months
|
Quality of life (Short-Form 36)
Time Frame: 3 months
|
Short-Form 36
|
3 months
|
Pain (Visual Analogic Scale)
Time Frame: 3 months
|
Visual Analogic Scale
|
3 months
|
Quality of Sleep (Pittsburgh Scale)
Time Frame: 3 months
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Pittsburgh Scale
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alesxandre Demoule, MD, PHD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K120103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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