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Completed

NCT Number: NCT01280942

Early Warning System for Clinical Deterioration on General Hospital Wards

The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.

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Key information

Conditions

Escalation of Care Apnea Cardiopulmonary Arrest Cardiovascular Diseases Clinical Deterioration Disease Attributes Disease Progression Heart Arrest Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Arrest Respiratory Tract Diseases Sepsis Septic Shock Severe Sepsis Shock Shock, Septic Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

Exclusion criteria

  • Minors, patients younger than 18 years old.

Treatment and study plan

EWS Nursing Alerts

Behavioral

An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.

Wireless Remote Sensor

Device

A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.

Primary outcomes

  1. Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm

    Time frame: Within 24 hrs of an EWS alert

    The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.

Secondary outcomes

  1. Clinical Outcomes and Process Measures

    Time frame: Hospital discharge

    length of stay

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Early Warning System for Clinical Deterioration on General Hospital Wards.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2011
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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