Monitoring vital signs of patients after standard bariatric surgery Outpatient surgery vital sign measurement
Conditions
Interventions
Patients in the active group will receive a Healthdot after surgery and will
leave the Hospital on the same day as surgery took place.
Sponsors
Philips Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult (equal or greater than 18) - Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team - Willing and able to sign informed consent form - Able to understand instructions - In possession of a telephone on which patient can be reached for the duration of participation (day 1-8) - An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.
Exclusion criteria
Exclusion criteria: - Patients of psychiatric wards, inmates of prisons, or other state institutions - Investigator or any other team member involved directly or indirectly in the conduct of the clinical study - Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (lower left rib) where the HealthDot needs to be placed - Known allergy for the tissue adhesive used in the Healthdot (white band-aid) - Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions) - Patient with active implantable such as Implantable Cardioverter Defibrillator (ICD) and pacemaker - Expected participation less than 8 days - Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed. - Patients with antibiotic resitant infections (e.g. MRSA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To evaluate whether performing bariatric surgery as outpatient surgery is not inferior to the current treatment based on a combined outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: * To assess Patient satisfaction (on a scale of 1-10) in both groups * To assess feasibility of outpatient recovery after standard bariatric surgery by evaluating recruitment rate, adherence to protocol and randomization, and the amount of missing data. * To evaluate the percentage and total number of false-positive notifications from the Healthdot system. * To evaluate the percentage of missed events (i.e. false negatives) from the Healthdot system. * To evaluate the total number of missed minor events from the Healthdot system. * To evaluate the outcome of patients who choose HD versus patients who were randomized to HD on a combined outcome measure as defined for the primary endpoint. * To compare the number of adverse events in both groups * To compare the use of pain medication during day of surgery until evening in both groups. * To compare the clinical decisions made on basis of remote monitoring with the Healthdot system, to decisions which also include information from a telephone consultation * To evaluate the impact of outpatient recovery after standard bariatric surgery and the Healthdot on patient and health professional satisfaction * To evaluate the costs involved with outpatient recovery after standard bariatric surgery supported by Healthdot. * To evaluate usability of the visualization of Healthdot data on the Guardian dashboard. | — |
Countries
Netherlands
Outcome results
None listed