DeliriumNCT01902277
ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
An observational study of Delirium, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jul 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients across eastern UK region
Who may be able to join
- Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 5EF
About this study
ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these.
The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).
Read the detailed description
Previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). Reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach.
Purpose: to obtain reliable data informing on prevalence of ICU delirium, in terms of both patients and beds, across the eastern UK region.
Design and Setting: this one-week observational prospective cohort study was carried out between June 25, 2012 (start of ICU day shift) to July 01, 2012 (end of night shift). Nine ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN) took part. Cambridgeshire 2 Research Ethics Committee approved the study (REC reference: 10/H0308/116) and waived the need for informed consent.
Patients and procedure: All adults treated over the study week at participating ICUs were considered eligible for inclusion. Delirium screening was carried out by patients' direct care clinicians using the Confusion Assessment Method for the ICU (CAM-ICU). All sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. Patients who screened positive for delirium were treated according to local hospital practice.
- Conditions
- Delirium
- Keywords
- Delirium, Intensive Care Unit, Critical illness
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult critically ill patients | All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium prevalence
Number of patients with at least one recorded delirium-positive result, over total number of patients recorded over study time frame. Delirium screening will be carried out using the CAM-ICU by local direct care clinicians in accordance with region-wide clinical delirium-screening guidelines.
Measured: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Secondary outcomes (11)
Proportion of patient-days with delirium
Number of patient-days with at least one recorded delirium-positive result over total patient-days recorded.
Measured: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median delirium duration
In delirium patients: median number of days recorded with delirium over study time frame.
Measured: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median days to transition to delirium
In delirium patients admitted during study time frame: median number of days from ICU admission to first recorded delirium day.
Measured: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient age, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: median age.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient gender, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of males over total patients in each group.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission type, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) urgent/emergency and (2) elective admissions, over total patients in each group.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission reason, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) medical and (2) surgical admissions, over total patients in each group.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Organ support, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving advanced and basic respiratory, advanced and basic cardiovascular, and renal support since ICU admission to end of study time frame, over total patients in each group.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Mobilisation therapy, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving mobilisation therapy over study time frame, over total patients in each group.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median ICU days, by delirium status
In delirium patients versus patients with no recorded delirium-positive result over study time frame: median number of patient-days in ICU per patient, since admission to end of study time frame.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Delirium screening compliance
Number of patient-days CAM-ICU administered (1) once or more and (2) twice or more, over total number of patient-days recorded over study time frame.
Measured: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)
- Responsible party
- Sponsor
- Investigators
- Alain Vuylsteke, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902277
- Sponsor's protocol ID
- P01535
- Status last verified
- Jul 2013
- First submitted
- 15 Jul 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
- ClinicalTrials.gov ID
- NCT01902277
- Acronym / sponsor ID
- P01535
- Conditions
- Delirium
- Keywords
- Delirium, Intensive Care Unit, Critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jul 2013 (estimated)
- 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.
ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these.
The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).
Detailed description
Previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). Reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach.
Purpose: to obtain reliable data informing on prevalence of ICU delirium, in terms of both patients and beds, across the eastern UK region.
Design and Setting: this one-week observational prospective cohort study was carried out between June 25, 2012 (start of ICU day shift) to July 01, 2012 (end of night shift). Nine ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN) took part. Cambridgeshire 2 Research Ethics Committee approved the study (REC reference: 10/H0308/116) and waived the need for informed consent.
Patients and procedure: All adults treated over the study week at participating ICUs were considered eligible for inclusion. Delirium screening was carried out by patients' direct care clinicians using the Confusion Assessment Method for the ICU (CAM-ICU). All sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. Patients who screened positive for delirium were treated according to local hospital practice.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult critically ill patients | – | –All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients across eastern UK region
Key inclusion criteria (1 listed)
- Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium prevalence
Time frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Number of patients with at least one recorded delirium-positive result, over total number of patients recorded over study time frame. Delirium screening will be carried out using the CAM-ICU by local direct care clinicians in accordance with region-wide clinical delirium-screening guidelines.
11 secondary outcomes
Proportion of patient-days with delirium
Time frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median delirium duration
Time frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median days to transition to delirium
Time frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient age, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient gender, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission type, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission reason, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Organ support, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Mobilisation therapy, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median ICU days, by delirium status
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Delirium screening compliance
Time frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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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.
Alain Vuylsteke, MD principal investigator
Papworth Hospital NHS Foundation Trust
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 Delirium, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 18 Jul 2013. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium prevalence (time frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)). 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 18 Jul 2013.