Skip to main content
OpenTrials
Completed

NCT Number: NCT01549717

Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Philips Intellivue Trx + SpO2

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

  1. The proportion of patient stay for which good quality continuous data is captured

  2. The number of alerts caused by probe off alarms and artefactual readings

  3. The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration

  4. The specificity of the automated early warning score developed from this data for predicting clinical deterioration

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Engineering and Physical Sciences Research Council, UK
  • King's College London
  • University of Oxford

Registry information

Acronym: LISTEN

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 9, 2012
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.