Critical CareNCT00506649
Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium
An observational study of Critical Care, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- What is being tested?
- protocol
- How many people
- 1,214 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2003to Nov 2005
- 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
Who may be able to join
- All adult patients admitted to ICU
Who cannot join
- Repeat admission within the same hospitalisation; moribund patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of no Protocol vs Protocolized Approach to Pain, Sedation and Delirium Management in the ICU
To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.
- Conditions
- Critical Care
- Being tested
- protocol
- Keywords
- protocol, analgesia, sedation, delirium, coma
- Medical subject headings
- Agnosia, Delirium, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolOther
management protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startAug 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yoanna Skrobik, MD FRCP(c), Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506649
- Sponsor's protocol ID
- 007
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of no Protocol vs Protocolized Approach to Pain, Sedation and Delirium Management in the ICU
- ClinicalTrials.gov ID
- NCT00506649
- Acronym / sponsor ID
- 007
- Conditions
- Critical Care
- Keywords
- protocol, analgesia, sedation, delirium, coma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Nov 2005 (actual)
- First posted
- 25 Jul 2007 (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.
To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients admitted to ICU
Key exclusion criteria (1 listed)
- Repeat admission within the same hospitalisation; moribund patients
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 |
|---|---|---|
| protocolmanagement protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium. | Other | – |
Primary outcome
Not reported in the source record.
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 25 Jul 2007.
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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.
Yoanna Skrobik, MD FRCP(c) principal investigator
Maisonneuve-Rosemont Hospital
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 Critical Care, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 25 Jul 2007. 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 Canada. 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.
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 25 Jul 2007.