Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring (LISTEN)
|ClinicalTrials.gov Identifier: NCT01549717|
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : February 12, 2014
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 or disease||Intervention/treatment||Phase|
|Monitoring of Patients Following Surgery||Device: Fitting of a wireless telemetry device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549717
|St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Richard Beale, MBBS||Guy's & St Thomas' Foundation Trust|