Critical IllnessCONFOCALNCT02344043
Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
An observational study of Critical Illness and Sepsis, run by Queen's University at 1 site in Canada.
Trial summary
Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Delirium
- What is being tested?
- Near infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Sep 2016
- 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: This study is recruiting critically ill patients admitted to the 33-bed medical/surgical intensive care unit at an academic medical centre.
Who may be able to join
- Critically ill patients defined as having either:
- Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of >24 hours, or:
- Shock: Defined as being on one of the following agents:
- norepinephrine (>5 mcg/min) IV
- epinephrine (at any dose)
- vasopressin (in combination with another pressor)
- milrinone (in combination with another pressor)
Who cannot join
- expected survival <24 hours
- history of cognitive dysfunction
- unable to participate in follow up testing
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications.
Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration.
Read more
Potential Harms, Risks or Discomforts:
This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.
Read the detailed description
A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.
- Conditions
- Critical Illness, Sepsis, Delirium, Respiratory Failure
- Being tested
- Near infrared spectroscopy
- Medical subject headings
- Critical Illness, Sepsis, Delirium, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDevice
This device uses near infrared spectroscopy to measure tissue oxygen levels (0-100%). The sensors are placed on the subjects' forehead to measure brain tissue oxygenation
| Study group | Role | What they receive |
|---|---|---|
| Critical illness | This prospective cohort of critically ill patients will have brain tissue oxygen levels recorded for 24 hours after admission with near infrared spectroscopy. Receives: Device: Near infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
The CAM-ICU and ICDSC are used to screen for delirium in critically ill patients. On the basis of these two validated screening tools, patients will be categorized as either comatose, delirious, or intact. The percentage of ICU stay that the participant spends delirious is the primary outcome measure.
Measured: Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.
Secondary outcomes (3)
Neurocognitive performance on KINARM tasks
The KINARM is a robotic device that provides quantitative metrics of the neurocognitive control of upper arm movements.
Measured: 3 and 12 months
Neurocognitive performance on the RBANS
The RBANS is the repeatable battery for the assessment of neuropsychological status
Measured: 3 and 12 months
Correlation between brain tissue oxygenation and physiological parameters
We will use correlation coefficients to describe the relationship between brain tissue oxygenation and physiological parameters recorded during the first 24 hours of critical illness.
Measured: First 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gordon Boyd, Queen's University
- Investigators
- John G Boyd, MD, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344043
- Sponsor's protocol ID
- DMED-1662-13
- Acronym
- CONFOCAL
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2015
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will publish our data in a peer reviewed scientific journal
Publications
Khan JM, Shore A, Lee KFH, Wood MD, Maslove DM, Hunt M, Georgescu I, Muscedere J, Boyd JG. Cerebral autoregulation-based mean arterial pressure targets and delirium in critically ill adults without brain injury: a retrospective cohort study. Can J Anaesth. 2024 Jan;71(1):107-117. doi: 10.1007/s12630-023-02609-w. Epub 2023 Nov 6.
PubMed 37932650Wood MD, Jacobson JA, Maslove DM, Muscedere JG, Boyd JG; Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group. The physiological determinants of near-infrared spectroscopy-derived regional cerebral oxygenation in critically ill adults. Intensive Care Med Exp. 2019 May 2;7(1):23. doi: 10.1186/s40635-019-0247-0.
PubMed 31049754Wood MD, Maslove DM, Muscedere J, Scott SH, Boyd JG; Canadian Critical Care Trials Group. Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. J Crit Care. 2018 Dec;48:228-236. doi: 10.1016/j.jcrc.2018.09.011. Epub 2018 Sep 12.
PubMed 30243203Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group; Canadian Critical Care Trials Group; Wood MD, Maslove DM, Muscedere JG, Day AG, Gordon Boyd J. Low brain tissue oxygenation contributes to the development of delirium in critically ill patients: A prospective observational study. J Crit Care. 2017 Oct;41:289-295. doi: 10.1016/j.jcrc.2017.06.009. Epub 2017 Jun 15.
PubMed 28668768
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness
- ClinicalTrials.gov ID
- NCT02344043
- Acronym / sponsor ID
- CONFOCAL / DMED-1662-13
- Conditions
- Critical Illness, Sepsis, Delirium, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jan 2015 (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.
Purpose of the Study Critical illness requiring life support affects over 150 000 people in Ontario every year. With aggressive support, the number of people who die from critical illness is decreasing. However, people who survive often have neurological problems. These neurological problems often include difficulties with memory, concentration, and attention. These problems are associated with poor quality of life among survivors of critical illness. The aim of this study is to identify the factors that contribute to these neurological deficits. Specifically, the investigators are testing whether changes in oxygen delivery to the brain during critical illness are related to both short- and long-term neurological complications.
Procedures involved in the Research When patients are diagnosed with a critical illness such as shock or respiratory failure, they are treated with intravenous fluids, medications to raise their blood pressure, and can be placed on a ventilator to assist with their breathing. They are observed in an intensive care unit (ICU). This research protocol does NOT interfere with the normal treatment of patients with critical illness. The procedure involved in this research protocol requires the placement of two stickers to either side of the patient's forehead, and information about oxygen delivery to the brain will be recorded. When the patient has recovered from the critical illness, they will be asked to perform several neurological tests. Some of these tests will be done with a pencil and paper, while others will use a robotic device to test arm movements, reaction time, and concentration.
Potential Harms, Risks or Discomforts:
This research study involves the placement of a sticker sensor to either side of the forehead. Rarely, patients may develop a rash to these electrodes. The investigators monitor patients very carefully for rashes, and if a rash is to occur, the sticker sensor will be removed. With regards to the neurological testing, rarely patients can have some mild muscle stiffness after moving their arms in the robot. The investigators do not expect any other further harms, risks, or discomforts.
Detailed description
A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical illness | – | Device: Near infrared spectroscopyThis prospective cohort of critically ill patients will have brain tissue oxygen levels recorded for 24 hours after admission with near infrared spectroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is recruiting critically ill patients admitted to the 33-bed medical/surgical intensive care unit at an academic medical centre.
Key inclusion criteria (7 listed)
- Critically ill patients defined as having either:
- norepinephrine (>5 mcg/min) IV
- epinephrine (at any dose)
- vasopressin (in combination with another pressor)
- milrinone (in combination with another pressor)
Key exclusion criteria (3 listed)
- expected survival <24 hours
- history of cognitive dysfunction
- unable to participate in follow up testing
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 |
|---|---|---|
| Near infrared spectroscopyThis device uses near infrared spectroscopy to measure tissue oxygen levels (0-100%). The sensors are placed on the subjects' forehead to measure brain tissue oxygenation | Device | Critical illness |
Primary outcome
Delirium
Time frame: Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.
The CAM-ICU and ICDSC are used to screen for delirium in critically ill patients. On the basis of these two validated screening tools, patients will be categorized as either comatose, delirious, or intact. The percentage of ICU stay that the participant spends delirious is the primary outcome measure.
3 secondary outcomes
Neurocognitive performance on KINARM tasks
Time frame: 3 and 12 months
Neurocognitive performance on the RBANS
Time frame: 3 and 12 months
Correlation between brain tissue oxygenation and physiological parameters
Time frame: First 24 hours of admission
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 28 Nov 2016.
- Derived from this study: PubMed 37932650Khan JM, Shore A, Lee KFH, Wood MD, Maslove DM, Hunt M, Georgescu I, Muscedere J, Boyd JG. Cerebral autoregulation-based mean arterial pressure targets and delirium in critically ill adults without brain injury: a retrospective cohort study. Can J Anaesth. 2024 Jan;71(1):107-117. doi: 10.1007/s12630-023-02609-w. Epub 2023 Nov 6.
- Derived from this study: PubMed 31049754Wood MD, Jacobson JA, Maslove DM, Muscedere JG, Boyd JG; Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group. The physiological determinants of near-infrared spectroscopy-derived regional cerebral oxygenation in critically ill adults. Intensive Care Med Exp. 2019 May 2;7(1):23. doi: 10.1186/s40635-019-0247-0.
- Derived from this study: PubMed 30243203Wood MD, Maslove DM, Muscedere J, Scott SH, Boyd JG; Canadian Critical Care Trials Group. Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. J Crit Care. 2018 Dec;48:228-236. doi: 10.1016/j.jcrc.2018.09.011. Epub 2018 Sep 12.
- Derived from this study: PubMed 28668768Cerebral Oxygenation and Neurological Outcomes Following Critical Illness (CONFOCAL) Research Group; Canadian Critical Care Trials Group; Wood MD, Maslove DM, Muscedere JG, Day AG, Gordon Boyd J. Low brain tissue oxygenation contributes to the development of delirium in critically ill patients: A prospective observational study. J Crit Care. 2017 Oct;41:289-295. doi: 10.1016/j.jcrc.2017.06.009. Epub 2017 Jun 15.
- Individual participant dataSharing planned: Yes. We will publish our data in a peer reviewed scientific journal
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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 G Boyd, MD, PhD principal investigator
Queen's University
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 Illness and Sepsis, run by Queen's University 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 7 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 28 Nov 2016. 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.
What does the primary outcome measure?
Delirium (time frame: Proportion of ICU stay spent delirious. The average ICU stay is 7 days at our institution, however, some patients may stay much longer. We will perform delirium screening to a maximum of 30 days after ICU admission.). 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 NCT02344043, which also lists 4 linked publications.
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 28 Nov 2016.