Respiratory FailureNIVILIUMNCT03880084
Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)
An observational study of Respiratory Failure and Delirium, run by University of Modena and Reggio Emilia at 1 site in Italy.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Delirium, Agitation,Psychomotor
- What is being tested?
- Observation
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena
Alessandro Marchioni
About this study
Official title: 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.
- Conditions
- Respiratory Failure, Delirium, Agitation,Psychomotor, Pain, Dyspnea, Mechanical Ventilation Complication
- Being tested
- Observation
- Medical subject headings
- Respiratory Insufficiency, Delirium, Psychomotor Agitation, Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days from Respiratory Intensive Care Unit admission
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days from Respiratory Intensive Care Unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880084
- Sponsor's protocol ID
- UModenaReggio 5
- Acronym
- NIVILIUM
- Status last verified
- May 2023
- First submitted
- 14 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Delirium, Agitation/Sedation, Pain and Dyspnea in Patients Admitted to Respiratory Intensive Care Unit for Acute Respiratory Failure (NIVILIUM)
- ClinicalTrials.gov ID
- NCT03880084
- Acronym / sponsor ID
- NIVILIUM / UModenaReggio 5
- Conditions
- Respiratory Failure, Delirium, Agitation,Psychomotor, Pain, Dyspnea, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationTo 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 | Other | – |
Primary outcome
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
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
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
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
4 secondary outcomes
The impact of delirium on Non Invasive Ventilation Success
Time frame: 30 days from Respiratory Intensive Care Unit admission
The impact of agitation on Non Invasive Ventilation Success
Time frame: 30 days from Respiratory Intensive Care Unit admission
The impact of pain on Non Invasive Ventilation Success
Time frame: 30 days from Respiratory Intensive Care Unit admission
The impact of dyspnea on Non Invasive Ventilation Success
Time frame: 30 days from Respiratory Intensive Care Unit admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Delirium, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Marchioni, MD (00390594225859, marchioni.alessandro@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: 7 days from Respiratory Intensive Care Unit admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.