Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

NCT01549717 | Completed

• 1 other identifier: 12/LO/0526
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• 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

Study Arms (1)

Elective cardiac surgery patients

EXPERIMENTAL

Patients undergoing elective cardiac surgery

Device: Fitting of a wireless telemetry device

Interventions

Fitting of a wireless telemetry device 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.

Also known as: Philips Intellivue Trx + SpO2

Elective cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (aged over 18 years old)
• Planned for elective cardiac surgery
• Post surgery care is planned to be on a study ward

You may not qualify if:

• Inability or refusal to consent
• Pregnant
• Prisoners
• For palliative care only

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Engineering and Physical Sciences Research Council, UK: collaborator
• King's College London: collaborator
• University of Oxford: collaborator

Study Sites (1)

St Thomas' Hospital

London, London, SE1 7EH, United Kingdom

Location

Study Officials

• Richard Beale, MBBS

  Guy's & St Thomas' Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

GB (1)