RecruitingACTRN12623001318673

A study exploring the use of continuous vital sign monitoring in acutely unwell general medical inpatients.

Automated vital sign monitoring devices in acutely unwell general medical inpatients: an exploratory study

Sponsor

Fisher & Paykel Healthcare Limited

Enrollment

63 participants

Start Date

Mar 7, 2024

Study Type

Observational

Conditions

Hyperoxaemia Impaired respiratory function Hypoxia Bradycardia Tachycardia

Summary

This observational study explores the use of three breathing and heart rate measurement devices that provide continuous monitoring of unwell hospital inpatients. One device attaches to the chest wall device with an adhesive patch to measure respiratory rate, a second device is worn around the wrist with a strap and has a finger probe attached to measure heart rate and oxygen saturation, and a third device is placed underneath the patient’s mattress and can measure heart rate and respiratory rate. People who provide informed consent to join the study will be monitored with these three devices for 48 hours while in hospital. The participants care while in hospital will not be influenced by their involvement in the study. Nurses will continue to monitor participants as they normally would, and the device measurements will not be visible to hospital staff during the study. The information gathered from the trial will be used to determine whether the new devices are accurate and reliable. Secondly this study will look at the influence of continuous breathing and heart rate monitoring on the New Zealand Early Warning Score system (NZEWS).

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Patients admitted under a medical team 24 hours
Anticipated to remain an inpatient in Wellington hospital for >24 hours
EWS greater than or equal to 4 at any time prior to the eligibility assessment

Exclusion Criteria12

Age less than 18
Planned surgical intervention requiring transfer to an operating theatre within 24 hours
Cardiac pacemaker
Primarily receiving end of life care (Goals of Care D)
HDB/ICU admissions
Invasive/non-invasive ventilation
Nasal high flow therapy
Imminent need for ICU admission (currently planning for ICU admission)
Meeting MET call criteria at eligibility assessment (EWS greater than or equal to 10 or any parameter in ‘blue zone’)
Practical reasons that a chest wall sensing device cannot be applied (MRI scanner, skin disease, dressings, etc.)
Cognitive impairment or impaired consciousness precluding informed consent and ability to co-operate with application of continuous monitoring devices
Pregnancy or breastfeeding

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This observational study explores the use of breathing and heart rate measurement devices that provide continuous monitoring of unwell hospital inpatients. These devices non-invasively detect patient

This observational study explores the use of breathing and heart rate measurement devices that provide continuous monitoring of unwell hospital inpatients. These devices non-invasively detect patient observations and communicate with a centralised computer. Using these devices, patient observations can be automatically collected and displayed for the use of medical staff caring for the patient. This study involves three new monitoring devices; one that attaches to the chest wall device with an adhesive patch to measure respiratory rate, one that is worn around the wrist with a strap and has a finger probe attached to measure heart rate and oxygen saturation, and another that is placed underneath the patient’s mattress and can measure heart rate and respiratory rate. The study is designed in two parts; the first to assess the agreement between vital sign recordings using novel devices compared to gold standard measurements, and the second to compare continuous vital sign monitoring with standard intermittent nursing observations. A total of 27 people who provide informed consent to join both parts (Part 1 and Part 2) of the study will be monitored with these three devices for 48 hours while in hospital. Each participant will have all three devices applied by a study investigator. The participants care while in hospital will not be influenced by their involvement in the study. Nurses will continue to monitor participants as they normally would, and the device measurements will not be visible to hospital staff during the study.