Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis

ConditionARDS, Human
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults admitted to the ICU with ARDS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Masimo O3 NIRS cerebral oximetry and SedLine processed EEG

    Device

    Non-invasive neuromonitoring device for observational study

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Acute Respiratory Distress Syndrome1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

Recruitment of two patients per month, allowing for seasonal variation in ARDS.

Time frame
20 months
2

Data Quality

Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt

Time frame
7 days

Secondary outcomes

1

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.

Time frame
7 days
2

MAPopt

Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.

Time frame
7 days

Other outcomes

Sponsors and contacts

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