Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880084
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Alessandro Marchioni, University of Modena and Reggio Emilia

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.

Condition or disease Intervention/treatment
Respiratory Failure Delirium Agitation,Psychomotor Pain Dyspnea Mechanical Ventilation Complication Other: Observation

Layout table for study information
Study Type : Observational
Estimated Enrollment : 92 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Delirium, Agitation/Sedation, Pain and Dyspnea in Patients Admitted to Respiratory Intensive Care Unit for Acute Respiratory Failure (NIVILIUM)
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Incidence of delirium [ Time Frame: 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

  2. Incidence of agitation [ Time Frame: 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

  3. Incidence of pain [ Time Frame: 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

  4. Incidence of dyspnea [ Time Frame: 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


Secondary Outcome Measures :
  1. The impact of delirium on Non Invasive Ventilation Success [ Time Frame: 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

  2. The impact of agitation on Non Invasive Ventilation Success [ Time Frame: 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

  3. The impact of pain on Non Invasive Ventilation Success [ Time Frame: 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

  4. The impact of dyspnea on Non Invasive Ventilation Success [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880084


Contacts
Layout table for location contacts
Contact: Alessandro Marchioni, MD 00390594225859 marchioni.alessandro@unimore.it

Locations
Layout table for location information
Italy
Azienda Ospedaliero Universitaria Policlinico di Modena Recruiting
Modena, Italy
Contact: Alessandro Marchioni         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Layout table for additonal information
Responsible Party: Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03880084    
Other Study ID Numbers: UModenaReggio 5
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Dyspnea
Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Dyskinesias
Psychomotor Disorders