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

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847634
• Other study ID #: HS25505
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 the ICU.

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:

1. SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.

2. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Masimo O3 NIRS cerebral oximetry and SedLine processed EEG
Non-invasive neuromonitoring device for observational study

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment of two patients per month, allowing for seasonal variation in ARDS.	20 months
Primary	Data Quality	Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt	7 days
Secondary	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.	7 days
Secondary	MAPopt	Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.	7 days