None listed
Conditions
Brief summary
Hypertension does not discriminate; it can affect anyone regardless of age, gender or fitness status. 6 Million Australians (34%) suffer from high blood pressure. Of these, 68% have uncontrolled or unmanaged high blood pressure. This means 4 million Australians are at a greatly increased risk of heart attack or stroke. Out of the 2 million people that are managed, 1 in 3 people measure blood pressure incorrectly at home with current BP monitors. 1 in 3 people have difficulty applying a conventional BP cuff. Tournicare Pty Ltd is developing a BP monitor, Tournicare, that promotes correct placement using only 1 hand. This trial aims to test the safety, accuracy and ease of use of Tournicare compared to a clinically validated home BP monitor. Tournicare will be tested on up to 30 generally healthy participants. Each participant will have their blood pressure measured multiple times over a 15 minute period. The participant will perform successive BP measurements followed coinciding measurements performed by a registered nurse with Tournicare on the left arm and the standard BP monitor on the right arm. The monitors will then switch arms and coinciding measurements will be repeated. During the process the participants will be asked questions regarding usability and user experience.
Interventions
Assessment of safety, accuracy and ease of use of the Tournicare BP monitor.
Location: Outerspace Design Office, Richmond, Melbourne, Australia.
Materials used: Tournicare BP monitor prototype, clinically validated upper arm BP monitor.
Each participant will spend approximately 15 minutes with a registered nurse (RN). Firstly the RN takes consent. Blood pressure will be measured in a quiet room with no stimulus (such as talking to participant, measuring arm or even patient reading/looking at pho
Assessment of safety, accuracy and ease of use of the Tournicare BP monitor. Location: Outerspace Design Office, Richmond, Melbourne, Australia. Materials used: Tournicare BP monitor prototype, clinically validated upper arm BP monitor. Each participant will spend approximately 15 minutes with a registered nurse (RN). Firstly the RN takes consent. Blood pressure will be measured in a quiet room with no stimulus (such as talking to participant, measuring arm or even patient reading/looking at phone), with the patient in the seated position, back and arm supported, Tournicare and/or cuff at heart level, after 5 minutes of rest. This is to ensure reproducibility. The participants will self-measure blood pressure with both Tournicare and a validated BP monitor. The RN will then perform 3 pairs of simultaneous BP measurements with e.g. Tournicare applied to the right upper arm and a validated BP monitor on the left. It is not uncommon for BP to differ slightly from left to right arm, this is why Tournicare and the validated BP monitor are then swapped and followed by another 3 pairs of measurements. During or after the process the participants will be asked questions regarding usability and user experience. In addition to BP measurements, age, gender and upper arm width and/or circumference will be recorded.
Sponsors
Tournicare Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Generally healthy adult participants
Exclusion criteria
People with large, obese arms (the Tournicare prototype adjusts to different arm widths but has an upper limit of 11cm), high blood pressure, a change from the normal heartbeat, thickening/hardening of the artery walls, low oxygen levels, diabetes, pregnancy, removal of one or both breasts, kidney disease or severe blood flow problems or blood disorders.
Outcome results
None listed