Early Warning System for Clinical Deterioration on General Hospital Wards

Septic Shock Clinical Trial

Official title:

Early Warning System for Clinical Deterioration on General Hospital Wards.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280942
• Other study ID #: 10-0514
• Secondary ID: 7322-01
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: February 7, 2018
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20031
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Minors, patients younger than 18 years old.

Related Conditions & MeSH terms

• Apnea
• Cardiopulmonary Arrest
• Escalation of Care
• Heart Arrest
• Respiratory Arrest
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic

Intervention

Behavioral:
• EWS Nursing Alerts
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.

Device:
• Wireless Remote Sensor
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.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm	The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.	Within 24 hrs of an EWS alert
Secondary	Clinical Outcomes and Process Measures	length of stay	Hospital discharge