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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Delirium; Respiratory Failure; Mechanical Ventilation Complication; Dyspnea; Agitation,Psychomotor
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Anticipated): 92

Contacts and Locations

• Study Contact: Name: Alessandro Marchioni, MD; Phone Number: 00390594225859; Email: marchioni.alessandro@unimore.it

Study Locations

• Italy
  • Modena, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico di Modena
    • Contact: Alessandro Marchioni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation not known for psychiatric disease or dementia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Signs and Symptoms, Respiratory; Delirium; Psychomotor Agitation; Respiratory Insufficiency; Dyspnea
• Other Study ID Numbers: UModenaReggio 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No