Surveillance Monitoring on General Wards

NCT ID: NCT03271216

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

422 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

no intervention

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Masimo Corporation

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00066847

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.