Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring (LISTEN)

February 11, 2014 updated by: Richard Beale, Guy's and St Thomas' NHS Foundation Trust

The investigators plan to study patients who have had cardiac surgery. Current standard practice is to monitor patients who have had cardiac surgery using wall-mounted monitors whilst they are on the Overnight Intensive Recovery (OIR) and the cardiac High Dependency Unit (HDU). The wall-mounted monitors monitor the vital signs continuously and alert the nurses if any abnormalities are detected. Once a patient is transferred from HDU to the cardiac surgery ward for the most part they are no longer connected to a continuous monitor. Instead, the majority of patients on the ward have their vital signs only intermittently checked during the day, using a "spot check monitor". There is a small minority, chosen on clinical grounds, who are assessed with wireless "telemetry" monitors for a day or two.

In this study the investigators will continuously monitor the vital signs of all enrolled patients from the time that they leave the operating theatre to the the time they are discharged from hospital. Whilst they are on OIR and HDU they will be monitored with the standard wall-mounted monitors in the normal fashion. When they then move to the ward the investigators will give all enrolled patients a telemetry monitor to wear as well as asking the nurses to check their vital signs with spot check monitors.

The investigators will also collect information about the patients' general state of health and record indicators of worsening in patients' condition so that the investigators can determine how changes in the vital signs relate to deterioration. Finally the investigators plan to survey the patients and nurses to understand their experiences of continuous monitoring and what needs to be changed to improve the patient experience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (aged over 18 years old)
  • Planned for elective cardiac surgery
  • Post surgery care is planned to be on a study ward

Exclusion Criteria:

  • Inability or refusal to consent
  • Pregnant
  • Prisoners
  • For palliative care only

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elective cardiac surgery patients
Patients undergoing elective cardiac surgery
Device: Fitting of a wireless telemetry device
Fitting of a Philips Intellivue Trx + SpO2 telemetry device. To be worn throughout patient stay except if being monitored using a standard bedside monitor or bathing.
Other Names:
  • Philips Intellivue Trx + SpO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number of patients in whom abnormal vital signs are detected by a continuous monitor more than an hour before they are detected according to standard ward practice

Secondary Outcome Measures

Outcome Measure
The proportion of patient stay for which good quality continuous data is captured
The number of alerts caused by probe off alarms and artefactual readings
The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration
The specificity of the automated early warning score developed from this data for predicting clinical deterioration

Collaborators and Investigators

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

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London
University of Oxford
Engineering and Physical Sciences Research Council, UK

Investigators

  • Principal Investigator: Richard Beale, MBBS, Guy's & St Thomas' Foundation Trust

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

December 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12/LO/0526

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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