Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring (LISTEN)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Monitoring of Patients Following Surgery |
Device: Fitting of a wireless telemetry device |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring |
- 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 [ Designated as safety issue: No ]
- The proportion of patient stay for which good quality continuous data is captured [ Designated as safety issue: No ]
- The number of alerts caused by probe off alarms and artefactual readings [ Designated as safety issue: No ]
- The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration [ Designated as safety issue: No ]
- The specificity of the automated early warning score developed from this data for predicting clinical deterioration [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Philips Intellivue Trx + SpO2
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| St Thomas' Hospital | |
| London, United Kingdom, SE1 7EH | |
| Principal Investigator: | Richard Beale, MBBS | Guy's & St Thomas' Foundation Trust |
More Information
No publications provided
| Responsible Party: | Richard Beale, Consultant, Guy's and St Thomas' NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01549717 History of Changes |
| Other Study ID Numbers: | 12/LO/0526 |
| Study First Received: | March 7, 2012 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
|
Early warning score Physiological score Track and trigger score Scoring system Physiological model |
Monitoring Patient monitoring Wireless monitoring Wearable monitor |
ClinicalTrials.gov processed this record on May 16, 2013