Surveillance Monitoring on General Wards

Cardiac Arrest Clinical Trial

Official title:

Surveillance Monitoring on General Wards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271216
• Other study ID #: IRB00066847
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: August 31, 2017
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study to determine if surveillance monitoring of general ward patients can reduce cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing workload.

Description:

The investigators placed a wired monitoring system (pulse oximetry, heart rate and respiratory rate) on every patient who arrived on a subject general post surgical ward who assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130, Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in the Electronic Medical Record (EMR) any alarms they responded to as to whether they were false (vital sign not out of range when rechecked) or true and what the response was. Responses ranged from nurse managed to notification of primary service to Rapid Response Activation to Code team activation as well as transfer to a higher level of care (operating room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• all post-surgical patients admitted to a post-operative general hospital ward

Exclusion Criteria:

• inability to understand English or provide verbal consent for data analysis

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• No intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value (PPV)	The PPV of the wired monitoring system (pulse oximetry, heart rate and respiratory rate) will be determined based on change in vital signs (HR<45 or >130, RR<6 or >20 and pulse oximetry <85) indicating clinical deterioration	6 months