None listed
Conditions
Brief summary
The purpose of the study is to validate the cardiac and respiratory vital signs form the Saiiv Medical vital signs monitoring kit against gold standard vital signs monitoring devices which have been approved by the Therapeutic Goods Administration (TGA).
Interventions
This is a pivotal validation study of the Saiiv wearable vital signs monitor and App. The Saiiv wearable vita signs monitor is a waist belt worn around the chest and upper abdominal region. Validation of cardiac and respiratory vital signs will be conducted against gold standard TGA approved devices in 40 healthy volunteers and 40 ventilated patients in ICU.
Validation will involve healthy volunteers having vital signs assessed laying down, sitting and during light activity. ICU patients will w
This is a pivotal validation study of the Saiiv wearable vital signs monitor and App. The Saiiv wearable vita signs monitor is a waist belt worn around the chest and upper abdominal region. Validation of cardiac and respiratory vital signs will be conducted against gold standard TGA approved devices in 40 healthy volunteers and 40 ventilated patients in ICU. Validation will involve healthy volunteers having vital signs assessed laying down, sitting and during light activity. ICU patients will wear the device and vital signs will be monitored. ICU participants will not be required to complete any tasks. Vital signs monitoring will be conducted by a study coordinator and healthcare worker (nurse or doctor). Health volunteers will be monitored in-clinic over a 2 hour period and if consented will take the study device home and wear it for 2 weeks (minimum of 2-hours/day). They will then return to the research site and conduct a second 2-hour in-clinic monitoring study after which they will be exited form the study. ICU participants will be fitted with a study monitoring device in ICU and monitored for a two-hour period after which they will be exited form the study. Participants will not be required to interact with the App during the validation (in-clinic) assessments. Healthy volunteers who consent to the home assessment will download a copy of the App on their smart phone and will be able to interact with the App. The study will occur in the hospital/ward setting and in ICU.
Sponsors
Medical Monitoring Solutions Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Volunteers must have given written informed consent before any study related activities are carried out and must be able to understand the full nature and purpose of the trial including possible risks. Ventilated participants will not be consented however patient’s Person Responsible will be informed of the study and asked to provide consent. 2. Female participants of childbearing potential must not be pregnant or nursing at the time of enrolment. 3. Must be able to be fitted with the device. 4. Provision of use of a Smart phone for the duration of the study, and willingness to download the App for at-home study. 5. If a Healthy participants who consent to the at-home study must be willing to use personal WIFI for App use and phone which has Bluetooth. 6. If in ICU arm admitted for ventilatory support using invasive ventilation as part of standard of care.
Exclusion criteria
1. Known skin sensitivities or allergies to elasticated products. 2. Broken skin or rashes on torso (where devices will be in contact with the skin). 3. Participant who, in the opinion of the investigator, is not a good candidate for the study. 4. Cardiac pacemaker or implantable defibrillator, known to require defibrillation. 5. Any medical intervention that would interfere with the study. 6. Participant with surgical wounds/dressing precluding the appropriate placement of the investigational device.
Outcome results
None listed