None listed
Conditions
Brief summary
All patients are monitored and reviewed by hospital staff after surgery. Monitoring is important as it helps doctors and nurses make decisions to your care after surgery to give you the best care and to respond to changes early. When monitoring picks up a complication after surgery early, it can help reduce complications and can reduce the recovery period for patients. This study is testing two new monitoring devices and if they can detect complications earlier than our hospitals current monitoring does. The devices will not replace the hospitals usual monitoring. The devices will collect data at the same time and then compare it to the usual care patients receive after surgery. The information collected by the two new devices will not be able to be seen by hospital staff. Hospital staff will be guided by the usual monitoring at Waikato hospital.
Interventions
A novel, non-invasive, semi-continuous underbed monitoring device (VitalDetect). Wireless using bluetooth to transmit data.
A second cutaneous device will be worn on the upper arm attached with a medical grade 3M sticker. RBI biometric Sensor, First in human study. Spectroscopic technique similar to pulse oximeter device. This device aims to detect biological phenomenon in the skin and coincides with vasoconstriction.
The under bed device will be applied pre-op for 15mins. Both devices will be
A novel, non-invasive, semi-continuous underbed monitoring device (VitalDetect). Wireless using bluetooth to transmit data. A second cutaneous device will be worn on the upper arm attached with a medical grade 3M sticker. RBI biometric Sensor, First in human study. Spectroscopic technique similar to pulse oximeter device. This device aims to detect biological phenomenon in the skin and coincides with vasoconstriction. The under bed device will be applied pre-op for 15mins. Both devices will be started in the PACU environment. Both devices will be worn at the same time. Unless the patient cannot tolerate the sticker on the forearm. This will be assessed by study staff daily and reviewed. The research staff will apply the devices. The devices will be used in the post-operative period until discharge from hospital. Data will be recorded while the patient is in their bed. Device data performance/quality can be seen by research staff only. Research staff will be available to problem solve caused in data loss/ poor quality with primary staff. Retrospective review of data will form the formal review of the agreement with usual care observations which will include digital and paper based observation recrods.
Sponsors
Fisher and Paykel
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Patients 18 years and older 2. Patients having elective cardiac surgery who require a sternotomy and cardiopulmonary bypass, OR 3. Patients having elective major non-cardiac surgery who require admission to a high-acuity postoperative location (high-acuity area -HAA, high-dependency unit -HDU, intensive care unit -ICU, enhanced recovery unit -ERU) after leaving the postoperative anaesthetic care unit (PACU). 4. Written informed consent prior to surgery
Exclusion criteria
Exclusion criteria : 1. Patients aged <18 years 2. Patients undergoing emergency or acute surgery 3. Non-English speakers 4. Non-New Zealand Residents 5. Patients who are not able to freely provide written consent (for example due to cognitive dysfunction) 6. Planned presence of an arterial line and invasive blood pressure monitoring for less than 12 hours postoperatively
Outcome results
None listed