Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)
Study Details
Study Description
Brief Summary
Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of delirium [7 days from Respiratory Intensive Care Unit admission]
The onset of delirium will be assessed through the Confusion Assessment Method for Intensive Care Unit 7 scale, ranges 0-7, values > 2 indicate the presence of delirium
- Incidence of agitation [7 days from Respiratory Intensive Care Unit admission]
The onset of delirium will be assessed through the Richmond Agitation Sedation Scale ranges +4 to -5, values > 0 indicate the presence of agitation, values < 0 indicate the presence of sedation
- Incidence of pain [7 days from Respiratory Intensive Care Unit admission]
The onset of delirium will be assessed through the Behavioral Pain Scale, ranges 3-12, values > 4 indicate the presence of pain
- Incidence of dyspnea [7 days from Respiratory Intensive Care Unit admission]
The onset of delirium will be assessed through the Borg scale, ranges 0-10, values > 0 indicate the presence of dyspnea
Secondary Outcome Measures
- The impact of delirium on Non Invasive Ventilation Success [30 days from Respiratory Intensive Care Unit admission]
The correlation between the onset of delirium and the failure rates of Non Invasive Ventilation Treatment will be assessed
- The impact of agitation on Non Invasive Ventilation Success [30 days from Respiratory Intensive Care Unit admission]
The correlation between the onset of agitation and the failure rates of Non Invasive Ventilation Treatment will be assessed
- The impact of pain on Non Invasive Ventilation Success [30 days from Respiratory Intensive Care Unit admission]
The correlation between the onset and level of pain and the failure rates of Non Invasive Ventilation Treatment will be assessed
- The impact of dyspnea on Non Invasive Ventilation Success [30 days from Respiratory Intensive Care Unit admission]
The correlation between the onset and level of dyspnea and the failure rates of Non Invasive Ventilation Treatment will be assessed
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation
Exclusion Criteria:
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age lower than 18
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Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission
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need for immediate orotracheal intubation
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pregnancy
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previously established psychiatric disease or dementia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliero Universitaria Policlinico di Modena | Modena | Italy |
Sponsors and Collaborators
- University of Modena and Reggio Emilia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UModenaReggio 5