Surveillance Monitoring on General Wards

August 31, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

422

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

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post-surgical patients on a general hospital ward

Description

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

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive predictive value (PPV)
Time Frame: 6 months
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

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

Masimo Corporation

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

February 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00066847

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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