DeliriumNCT00919698
Delirium in Mechanically Ventilated Patients
An observational study of Delirium, run by University of Chicago at 1 site in United States.
Trial summary
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2013
- 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 patients (> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.
Who may be able to join
- > 18 years old
- intubated and mechanically ventilated
- receiving sedative and/or analgesic medication
- candidate for daily awakening from sedative and/or analgesic medication
Who cannot join
- primary neurologic disease (stroke, seizure, elevated ICP)
- post cardiac arrest
- do not speak English (assessment only English language validated)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.
Read the detailed description
This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.
- Conditions
- Delirium
- Keywords
- Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care
- Medical subject headings
- Delirium, Respiratory Aspiration
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 |
|---|---|---|
| Sedated mechanically ventilated patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Measured: Daily
Secondary outcomes (6)
ICU admitting diagnosis
Measured: At enrollment
Medications
Measured: Daily
Ventilator free days (or first 28)
Measured: At 28 days post-intubation
ICU complications
Measured: Daily
Days to discharge
Measured: At discharge
Survival
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919698
- Sponsor's protocol ID
- 16938B
- Status last verified
- Dec 2014
- First submitted
- 10 Jun 2009
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.
PubMed 24423152
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation
- ClinicalTrials.gov ID
- NCT00919698
- Acronym / sponsor ID
- 16938B
- Conditions
- Delirium
- Keywords
- Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Jun 2009 (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.
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.
Detailed description
This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedated mechanically ventilated patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.
Key inclusion criteria (4 listed)
- > 18 years old
- intubated and mechanically ventilated
- receiving sedative and/or analgesic medication
- candidate for daily awakening from sedative and/or analgesic medication
Key exclusion criteria (3 listed)
- primary neurologic disease (stroke, seizure, elevated ICP)
- post cardiac arrest
- do not speak English (assessment only English language validated)
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
Time frame: Daily
6 secondary outcomes
ICU admitting diagnosis
Time frame: At enrollment
Medications
Time frame: Daily
Ventilator free days (or first 28)
Time frame: At 28 days post-intubation
ICU complications
Time frame: Daily
Days to discharge
Time frame: At discharge
Survival
Time frame: At discharge
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 3 Dec 2014.
- Derived from this study: PubMed 24423152Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.
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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.
John P Kress, MD principal investigator
University of Chicago
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 University of Chicago at 1 site in United States.
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 4 inclusion and 3 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 3 Dec 2014. 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 States. 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 (time frame: Daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919698, which also lists 1 linked publication.
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 3 Dec 2014.