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Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01549717
Acronym
LISTEN
Enrollment
300
Registered
2012-03-09
Start date
2012-12-31
Completion date
2014-02-28
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monitoring of Patients Following Surgery

Keywords

Early warning score, Physiological score, Track and trigger score, Scoring system, Physiological model, Monitoring, Patient monitoring, Wireless monitoring, Wearable monitor

Brief summary

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.

Interventions

DEVICEFitting 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.

Sponsors

Engineering and Physical Sciences Research Council, UK
CollaboratorOTHER
King's College London
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026