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

Pain Clinical Trial

— NIVILIUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880084
• Other study ID #: UModenaReggio 5
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2023
• Source: University of Modena and Reggio Emilia
• Contact: Alessandro Marchioni, MD
• Phone: 00390594225859
• Email: marchioni.alessandro[@]unimore.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: January 1, 2025
• Est. primary completion date: August 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Delirium
• Dyspnea
• Mechanical Ventilation Complication
• Pain
• Psychomotor Agitation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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