Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness (CONFOCAL)

November 25, 2016 updated by: Dr. Gordon Boyd, Queen's University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A detailed protocol is currently under review for funding at Physician Services Incorporated, and can be included pending decision.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L3V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study is recruiting critically ill patients admitted to the 33-bed medical/surgical intensive care unit at an academic medical centre.

Description

Inclusion Criteria:

  • Critically ill patients defined as having either:

    1. Respiratory failure: Defined as invasive mechanical ventilation for a predicted duration of >24 hours, or:
    2. 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)

Exclusion Criteria:

  • expected survival <24 hours
  • history of cognitive dysfunction
  • unable to participate in follow up testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Near infrared spectroscopy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive performance on KINARM tasks
Time Frame: 3 and 12 months
The KINARM is a robotic device that provides quantitative metrics of the neurocognitive control of upper arm movements.
3 and 12 months
Neurocognitive performance on the RBANS
Time Frame: 3 and 12 months
The RBANS is the repeatable battery for the assessment of neuropsychological status
3 and 12 months
Correlation between brain tissue oxygenation and physiological parameters
Time Frame: First 24 hours of admission
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.
First 24 hours of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: John G Boyd, MD, PhD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 25, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-1662-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will publish our data in a peer reviewed scientific journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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