ARDS, HumanNCT05847634
Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
An observational study of ARDS, Human, run by University of Manitoba at 1 site in Canada.
Trial summary
Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Masimo O3 NIRS cerebral oximetry and SedLine processed EEG
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults admitted to the ICU with ARDS
Who may be able to join
- Adult patient admitted to the ICU
- ARDS confirmed according to the Berlin Definition
- Invasive mechanical ventilation
- Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team
- Application of monitoring devices feasible
Who cannot join
- More than 24 hours elapsed since ICU admission
- Death is deemed imminent and inevitable during the next 24 hours
- Known allergy to a textile component of the device
- Consent declined from patient or authorized third party
- The treating clinician believes that participation in the study would not be in the best interest of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3T2N2
Asher Mendelson, MD PhD, 2047878059, asher.mendelson@umanitoba.ca
About this study
Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.
Read the detailed description
The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.
To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:
- SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
- MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.
Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.
- Conditions
- ARDS, Human
- Being tested
- Masimo O3 NIRS cerebral oximetry and SedLine processed EEG
- Keywords
- Near-Infrared Spectroscopy, Depth of Sedation, Intensive Care Unit, Electroencephalography, Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo O3 NIRS cerebral oximetry and SedLine processed EEGDevice
Non-invasive neuromonitoring device for observational study
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Distress Syndrome | Adults admitted to ICU with ARDS confirmed according to Berlin Definition Receives: Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment of two patients per month, allowing for seasonal variation in ARDS.
Measured: 20 months
Data Quality
Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt
Measured: 7 days
Secondary outcomes (2)
SEDopt
Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and total hemoglobin (THb) as measure by O3 NIRS and processed EEG monitoring as defined by SedLine PSi.
Measured: 7 days
MAPopt
Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start25 Nov 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Mendelson, University of Manitoba
- Investigators
- Asher Mendelson, MD PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847634
- Sponsor's protocol ID
- HS25505
- Status last verified
- Dec 2024
- First submitted
- 27 Apr 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
- ClinicalTrials.gov ID
- NCT05847634
- Acronym / sponsor ID
- HS25505
- Conditions
- ARDS, Human
- Keywords
- Near-Infrared Spectroscopy, Depth of Sedation, Intensive Care Unit, Electroencephalography, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- 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.
Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.
Detailed description
The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.
To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:
- SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
- MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.
Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Distress Syndrome | – | Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEGAdults admitted to ICU with ARDS confirmed according to Berlin Definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the ICU with ARDS
Key inclusion criteria (5 listed)
- Adult patient admitted to the ICU
- ARDS confirmed according to the Berlin Definition
- Invasive mechanical ventilation
- Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team
- Application of monitoring devices feasible
Key exclusion criteria (5 listed)
- More than 24 hours elapsed since ICU admission
- Death is deemed imminent and inevitable during the next 24 hours
- Known allergy to a textile component of the device
- Consent declined from patient or authorized third party
- The treating clinician believes that participation in the study would not be in the best interest of the patient
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 |
|---|---|---|
| Masimo O3 NIRS cerebral oximetry and SedLine processed EEGNon-invasive neuromonitoring device for observational study | Device | Acute Respiratory Distress Syndrome |
Primary outcome
Recruitment
Time frame: 20 months
Recruitment of two patients per month, allowing for seasonal variation in ARDS.
Data Quality
Time frame: 7 days
Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt
2 secondary outcomes
SEDopt
Time frame: 7 days
MAPopt
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Asher Mendelson, MD PhD principal investigator
University of Manitoba
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 ARDS, Human, run by University of Manitoba 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asher Mendelson, MD PhD (204-787-8059, asher.mendelson@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 20 months). The study lists 2 primary outcomes in all. 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 6 Dec 2024.