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

Recruiting

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

• Registration Number: NCT03880084
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Study Start: 2019-08-01
• Primary Completion: 2020-08-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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 Outcome Measures

Name	Time	Method
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 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 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
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

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy