Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

Not Applicable

Completed

• Conditions: Monitoring of Patients Following Surgery
• Interventions: Device: Fitting of a wireless telemetry device

• Registration Number: NCT01549717
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-09
• Study Start: 2012-12
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elective cardiac surgery patients	Fitting of a wireless telemetry device	Patients undergoing elective cardiac surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of alerts caused by probe off alarms and artefactual readings
The specificity of the automated early warning score developed from this data for predicting clinical deterioration
The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration
The proportion of patient stay for which good quality continuous data is captured

Trial Locations

Locations (1)

St Thomas' Hospital; 🇬🇧 London, United Kingdom