Clinical trial NCT01549717: Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring
Official title: Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Engineering and Physical Sciences Research Council, UK
name: King's College London
name: University of Oxford
First posted: 2012-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
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 outcomes:
measure: The proportion of patient stay for which good quality continuous data is captured
measure: The number of alerts caused by probe off alarms and artefactual readings
measure: The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration
measure: The specificity of the automated early warning score developed from this data for predicting clinical deterioration
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: Guy's & St Thomas' Foundation Trust
name: Richard Beale, MBBS
role: PRINCIPAL_INVESTIGATOR
References: