Critical Health Assessment and Outcomes Score/Study

NCT ID: NCT02766166

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2027-09-01

Brief Summary

CHAOS is based on the investigator's new and exciting results from pre-clinical and large longitudinal multi-center observational clinical studies of critically ill patients and asymptomatic community-based adults with little or no advanced disease.

By integrating approaches from the physical, biological, computational, statistical and clinical sciences, this observational study will test the hypothesis that early diagnosis of subclinical signatures of critical illness encoded within physiological signals complements conventional clinical predictors by providing unique prognostic insight.

The primary goal is to reduce mortality, morbidity and complications by early identification of individuals with brewing subclinical critical illness and adverse events before overt clinical presentation (e.g., cardiac arrest, arrhythmias, hemorrhage, respiratory failure, circulatory collapse). This will provide the necessary lead time for healthcare providers to deliver early, more effective and/or preventive therapies. Through innovative approaches, CHAOS also meets the challenge of medical errors to reduce missed diagnosis, misdiagnosis, preventable harm and variability in provider adherence to best practice guidelines.

The goal is to validate predictive algorithms and identify subclinical signatures of illness, ranging from asymptomatic adults in the community to very sick patients in the hospital. The overall goal is to make healthcare more precise, effective, efficient, safe and timely while reducing costs, preventable harms and adverse events.

Conditions

Critical Illness; Death, Sudden

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Predictive Monitoring

No interventions assigned to this group

No Predictive Monitoring

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All patients age 18-100 years admitted to a bed or OR with telemetry monitoring capability will be included.

Exclusion Criteria

• Children (individuals <18 years of age).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: NOT_YET_RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deeptankar DeMazumder, MD, PhD

Role: CONTACT

DDeMazu@iu.edu

513-558-1035

Deeptankar DeMazumder, MD, PhD

Role: CONTACT

Deeptankar@gmail.com

513-558-1035

Facility Contacts

Deeptankar DeMazumder, MD, PhD

Role: primary

DDeMazu@iu.edu

Steven R. Jones, MD

Role: primary

sjones64@jhmi.edu

Deeptankar DeMazumder, MD, PhD

Role: backup

DDeMazu@iu.edu

Benjamin L. Vaughan, PhD

Role: primary

vaughabn@ucmail.uc.edu

Deeptankar DeMazumder, MD, PhD

Role: backup

DDeMazu@iu.edu

Other Identifiers

CR02_2017-5045 (central IRB)

Identifier Type: -

Identifier Source: org_study_id