Agitation,Psychomotor, Delirium, Dyspnea, Mechanical Ventilation Complication, Pain, Respiratory Failure
Conditions
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.
Interventions
OTHERObservation
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
Sponsors
University of Modena and Reggio Emilia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactAlessandro Marchioni, MD
Outcome results
None listed