CONFOCAL-2 Interventional Pilot Study

Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2) Interventional Pilot Study

This study is designed to assess the feasibility of identifying and administering individualized blood pressure targets early critical illness. Recent literature suggests that individualized targets adapted to cerebral perfusion and autoregulation capacity may improve patient outcomes. In this study, cerebral autoregulation capacity is assessed by simultaneous trending of near-infared spectroscopy and arterial blood pressure for 24 hours, within patients' first 2 days in the ICU. The investigators will assess the feasibility of identifying patients' personal targets, then treating patients according to their personal targets for 48 hours. Clinical outcomes explored will include delirium.

Study Overview

• Status: Completed
• Conditions: Delirium; Shock; Critical Illness; Respiratory Failure
• Intervention / Treatment: Drug: Autoregulation-based precision blood pressure management

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Admitted to a critical care unit requiring one or more of the following:

   1. Respiratory failure requiring invasive mechanical ventilation with an expected duration >24 hours or
   2. Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: i. Dopamine ≥7.5 mcg/kg/min, ii. Dobutamine ≥5 mcg/kg/min, iii. Norepinephrine ≥5 mcg/min, iv. Phenylephrine ≥75 mcg/min, v. Epinephrine at any dose, vi. Milrinone at any dose (if used in conjunction with another agent), vii. Vasopressin ≥0.03 u/min (if used in conjunction with another agent)
2. Presence of an arterial line

Exclusion Criteria:

1. Admission to the ICU > 24 hours
2. Life expectancy <24 hours
3. Primary central nervous system admitting diagnosis (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage, cardiac arrest).
4. Pregnancy
5. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autoregulation-based precision blood pressure management; Blood pressure maintenance based on cerebral oximetry autoregulation measurement.	Drug: Autoregulation-based precision blood pressure management; Blood pressure maintenance based on cerebral oximetry autoregulation measurement. Blood pressure is raised or lowered via norepinephrine (dose range 1-10 mcg/min) and labetalol (dose range 0-2 mg/min), respectively, to match the researched blood pressure targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Target recruitment rate = 1 patient/month	From period of study start to finish, an average of one year.
Determine optimal mean arterial pressure target (MAPopt)	Aim to determine MAPopt in >75% of patients within the first 24 hours	For 24 hours after enrollment
Maintain MAP within MAPopt range	Aim to maintain patients in MAPopt range for >90% of the time for 48 hours	for 24-72 hours after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between delirium and cerebral autoregulation	Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with dysfunctional cerebral autoregulation and the duration of time with delirium.	Up to day 30 after ICU admission or the day of patient discharge
Correlation between delirium and time outside MAPopt	Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with dysfunctional cerebral autoregulation and the duration of time with delirium.	Up to day 30 after ICU admission or the day of patient discharge
Exploratory short-term delirium outcomes	Patients will be assessed daily for delirium throughout their entire hospital stay (ICU and ward; up to day 30) using a validated screening tool; the Confusion Assessment Method (CAM)-ICU while in ICU, and the Confusion Assessment Method (CAM) while on the ward. Trained researchers will administer the CAM-ICU once daily, at a time that is convenient for the patient, their family, and the medical team directing their care. The ICU discharge day will be considered to be the day that the attending writes orders to discharge to avoid the influence of delayed ICU discharge because of the lack of ward beds. We will calculate the correlation between the proportion of time spent with outside of MAPopt and the duration of time with delirium.	Up to day 30 after ICU admission or the day of patient discharge

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): February 8, 2025
• Study Completion (Actual): February 8, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: neurocognitive; cerebral oximetry; precision medicine; post-ICU syndrome; near-infared spectroscopy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Respiratory Insufficiency; Critical Illness; Shock
• Other Study ID Numbers: 6033269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are open to sharing individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, appendices). Data sharing would be available to interested researchers for IPD meta-analysis or other research aims for which IPD is necessary. Proposals should be directed to study contact Dr. Gordon Boyd at Gordon.Boyd@kingstonhsc.ca. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and received ethics approval for their proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No