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

NCT03880084 | Unknown

• 1 other identifier: UModenaReggio 5
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• The impact of delirium on Non Invasive Ventilation Success

  30 days from Respiratory Intensive Care Unit admission

• The impact of agitation on Non Invasive Ventilation Success

  30 days from Respiratory Intensive Care Unit admission

• The impact of pain on Non Invasive Ventilation Success

  30 days from Respiratory Intensive Care Unit admission

• The impact of dyspnea on Non Invasive Ventilation Success

  30 days from Respiratory Intensive Care Unit admission

Interventions

Observation OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Delirium; Psychomotor Agitation; Pain; Dyspnea

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Alessandro Marchioni, MD

CONTACT

00390594225859; marchioni.alessandro@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (1)