Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)

Study Overview
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Brief Summary
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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.

Official Title
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Longitudinal Assessment of Delirium, Agitation/Sedation, Pain and Dyspnea in Patients Admitted to Respiratory Intensive Care Unit for Acute Respiratory Failure (NIVILIUM)

Conditions
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Respiratory Failure, Delirium, Agitation,Psychomotor, Pain, Dyspnea, Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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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: age lower than 18 Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission need for immediate orotracheal intubation pregnancy previously established psychiatric disease or dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|To systematically assess the onset of delirium, quantify the level of agitation/sedation, estimate the grade of pain and survey the level of dyspnea in patients undergoing non invasive mechanical ventilation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | 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 | 7 days from Respiratory Intensive Care Unit admission | 
| Incidence of agitation | 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 | 7 days from Respiratory Intensive Care Unit admission | 
| Incidence of pain | The onset of delirium will be assessed through the Behavioral Pain Scale, ranges 3-12, values > 4 indicate the presence of pain | 7 days from Respiratory Intensive Care Unit admission | 
| Incidence of dyspnea | The onset of delirium will be assessed through the Borg scale, ranges 0-10, values > 0 indicate the presence of dyspnea | 7 days from Respiratory Intensive Care Unit admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of delirium on Non Invasive Ventilation Success | The correlation between the onset of delirium and the failure rates of Non Invasive Ventilation Treatment will be assessed | 30 days from Respiratory Intensive Care Unit admission | 
| The impact of agitation on Non Invasive Ventilation Success | The correlation between the onset of agitation and the failure rates of Non Invasive Ventilation Treatment will be assessed | 30 days from Respiratory Intensive Care Unit admission | 
| The impact of pain on Non Invasive Ventilation Success | The correlation between the onset and level of pain and the failure rates of Non Invasive Ventilation Treatment will be assessed | 30 days from Respiratory Intensive Care Unit admission | 
| The impact of dyspnea on Non Invasive Ventilation Success | The correlation between the onset and level of dyspnea and the failure rates of Non Invasive Ventilation Treatment will be assessed | 30 days from Respiratory Intensive Care Unit admission |