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Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring (LISTEN)

This study has been completed.
Sponsor:
Collaborators:
Engineering and Physical Sciences Research Council, UK
King's College London
University of Oxford
Information provided by (Responsible Party):
Richard Beale, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01549717
First received: March 7, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Monitoring of Patients Following Surgery
Device: Fitting of a wireless telemetry device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patient stay for which good quality continuous data is captured [ Designated as safety issue: No ]
  • The number of alerts caused by probe off alarms and artefactual readings [ Designated as safety issue: No ]
  • The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration [ Designated as safety issue: No ]
  • The specificity of the automated early warning score developed from this data for predicting clinical deterioration [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549717

Locations
United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Engineering and Physical Sciences Research Council, UK
King's College London
University of Oxford
Investigators
Principal Investigator: Richard Beale, MBBS Guy's & St Thomas' Foundation Trust
  More Information

No publications provided

Responsible Party: Richard Beale, Consultant, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01549717     History of Changes
Other Study ID Numbers: 12/LO/0526
Study First Received: March 7, 2012
Last Updated: February 11, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Early warning score
Physiological score
Track and trigger score
Scoring system
Physiological model
Monitoring
Patient monitoring
Wireless monitoring
Wearable monitor

ClinicalTrials.gov processed this record on November 19, 2014