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DeliriumdelricuNCT00611377

Study on the Incidence of Delirium in a Respiratory Weaning Centre

An observational study of Delirium, run by Fondazione Salvatore Maugeri at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Delirium is rather common among patients in Intensive Care Units (ICU), while little is known about its incidence in ventilator-dependent patients transferred to a Weaning Center (WC), once in a phase of clinical stability. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Delirium
How many people
200 participants
Where
1 siteItaly
Study dates
Jan 2007to Mar 2008
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We will evaluate for the presence of delirium all the ventilator-dependent patients admitted to our RWC. They will be monitored using the Intensive Care Delirium Screening Checklist (ICDSC). This evaluation is based on a score based on 8 items obtained with a simple examination by the attending physician. The final sum generates a score considered normal (0-1), borderline (2-3) and pathologic (>4). All the patients, except those with normal score, will also be evaluated by a psychiatrist, using the Diagnostic Manual of Mental Disorders (DSM-IV), considered the gold standard. The score will be assessed at patient's admission, at mid-hospital stay and at discharge.

Who may be able to join

  • All patients admitted in the respiratory weaning centre

Who cannot join

  • Patients in deep coma
  • Deceased or transferred to another ward within 72 hours of admission

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Department of respiratory medicine and intensive care unit

    Pavia, PV, 27100

    Piero M Ceriana, MD, 39 0382592 ext. 804, piero.ceriana@fsm.it

    Piero M Ceriana, MD

    Recruiting

Other trials in Italy

About this study

Official title: Delirium in Patients Admitted to a Respiratory Weaning Centre: Analysis of Incidence and Risk Factor

Delirium is rather common among patients in Intensive Care Units (ICU), while little is known about its incidence in ventilator-dependent patients transferred to a Weaning Center (WC), once in a phase of clinical stability. We will prospectively evaluate for the presence of delirium all the ventilator-dependent patients admitted to our WC over a period of two years. They will be monitored using the Intensive Care Delirium Screening Checklist (ICDSC), previously validated in the ICU setting. This evaluation is based on a score based on 8 items obtained with a simple examination by the attending physician. The final sum generates a score considered normal (0-1), borderline (2-3) and pathologic (>4). All the patients, except those with normal score, will also be evaluated by a psychiatrist, using the Diagnostic Manual of Mental Disorders (DSM-IV), considered the gold standard. The score will be assessed at patient's admission, at mid-hospital stay and at discharge.

Read the detailed description

Delirium has been defined, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV), as a disturbance of consciousness characterized by an acute onset and fluctuating course. This impairment of cognitive functions, not being accounted for by a pre-existing dementia, reduces the patient's ability to receive, process and recall informations and its main features are inattention, disorganized thinking and reduced clarity of awareness of the environment.

All patients transferred from an intensive care unit to our respiratory weaning centre (RWC) will be screened for the occurrence of delirium. Our RWC is a 7-bed unit located within the respiratory department of a rehabilitation hospital and is fully equipped for invasive and non-invasive mechanical ventilation (MV) and for invasive and noninvasive cardiorespiratory monitoring. Patients are generally transferred to our unit from a general or surgical ICU for weaning from MV or, in case of patients already weaned, for rehabilitation, monitoring and intensive nursing care. All patients or their next of kin will give written informed consent to participate to the study and the study protocol has been approved by the local ethics committee.

For the assessment of delirium we use the Intensive Care Delirium Screening Checklist (ICDSC),a diagnostic tool already validated in the intensive care setting even in mechanically ventilated patients. It is based on the assessment of 8 different items dealing with the patient's mental status: each one is scored 0 or 1 in case of, respectively, absence or presence of the item itself and the final score is the resultant of the sum of the different items (see the appendix 1 for further details). The evaluation is performed on a daily basis by the physician in charge and the ICDSC score is ranked in the following way: 0 to 1 is considered normal, 2 to 3 is considered borderline, (i.e. indicative of a subsyndromal delirious state) and 4 or greater is considered diagnostic for delirium (13). In presence of a score greater than 1 the psychiatrist is called for consultation and diagnostic confirmation. Upon discharge of the patient from our RWC a score trend is drawn for every patient using the three highest scores sampled during the phases of admission, of mid stay and of discharge. Cases of overt delirium (only patients with ICDSC score ≥4) are categorized as hyperactive or hypoactive, according to a currently accepted classification. Treatment of delirium, when properly diagnosed, is instituted according to the psychiatist's prescriptions.

Patient's data collection include demographic data (age, gender), severity score (SAPS II), reason for admission (i.e. need for mechanical ventilation (MV) or not (NMV)) and previous episodes of delirium (hyperactive forms) occurring during ICU stay not linked to a pre-existing mental disease or to an acquired brain failure of vascular, metabolic or infectious origin. The Kelly scale is used for the assessment of the level of consciousness: the patient is considered comatose in presence of a persistent (>24 hours) Kelly score of ≥4. As far as the use of sedatives and analgesics in our RWC is concerned, our policy is based on the avoidance of continuous infusions regimens and on the limitation to the use of those drugs with a known or suspected capability to induce delirium; each drug is prescribed when strictly needed according to the judgement of the physician on duty and is targeted to the treatment of the specific symptom: pain, anxiety, insomnia etc.

Analysis of variance for repeated measures (MANOVA) is employed for statistical analysis, and a p value lower than 0.05 is considered the threshold value for statistical significance.

Conditions
Delirium
Keywords
delirium, mechanical ventilation, age, severity score
Medical subject headings
Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00611377
Study groupRoleWhat they receive
1Not described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2008 (estimated)
  4. Study completionMar 2008 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611377
Sponsor's protocol ID
delirium in rwc
Other IDs
deliriumPavia
Acronym
delricu
Status last verified
Jan 2008
First submitted
28 Jan 2008
Last updated
8 Feb 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium, run by Fondazione Salvatore Maugeri 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 2 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 8 Feb 2008. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

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 8 Feb 2008.

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