Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

NCT ID: NCT01549717

Last Updated: 2014-02-12

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Monitoring of Patients Following Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Elective cardiac surgery patients

Patients undergoing elective cardiac surgery

Group Type EXPERIMENTAL

Fitting of a wireless telemetry device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Philips Intellivue Trx + SpO2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engineering and Physical Sciences Research Council, UK

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Richard Beale

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Beale, MBBS

Role: PRINCIPAL_INVESTIGATOR

Guy's & St Thomas' Foundation Trust

Locations

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St Thomas' Hospital

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12/LO/0526

Identifier Type: -

Identifier Source: org_study_id

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