To evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data calculated based on accelerometer and/or PPG measurements
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patients, scheduled for surgery e.g. bariatric and major surgery such as cyto reductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC), complex rectal surgery, esophagectomy and pancreatectomy
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to evaluate the sensitivity and specificity for the
prediction of deterioration after surgery using the data calculated based on
accelerometer and/or PPG measurements.
Secondary outcome
* Agreement of the calculated heart rate and respiratory rate compared to the
gold standard.
* Description of the extent of hampering in daily activities by both devices as
assessed by the patients.
Background summary
Postoperative complications are frequently encountered at the surgical ward.
Complications can lead to major adverse events such as unplanned intensive care
unit (ICU) admissions, cardiorespiratory arrest or even death with a
postoperative in-hospital mortality rate of 4%. They are also associated with
prolonged length of stay. Timely detection of patients at risk of complications
is important to initiate appropriate treatment and prevent major adverse
events. Various strategies have been developed and studied to reduce the number
of adverse events. Risk stratification is applied in the pre- and
intra-operative setting by taking into account patient characteristics and
vital signs. Studies show that of all vital signs measured heart rate and
respiratory rate are the most predictive for deterioration of health. In this
study two technologies (accelerometer and photoplethysmography) will be tested
to assess i.a. heart rate and respiratory rate of patients during the
transition from hospital to home. Data will be analysed retrospectively after
the study has been closed out and the vital signs will be compared to
readmission and adverse events to see if the events could have been predicted
due to the device measurements. No clinical decisions or intervention will be
performed based on the measurements done during the study.
Study objective
To evaluate the sensitivity and specificity for the prediction of deterioration
after surgery using the data calculated based on accelerometer and/or PPG
measurements
Study design
This is a study at one site in the Netherlands. No randomization or blinding
will be done. Patients with elective surgery will wear two devices (HealthDot
and Elan) after surgery in hospital and after discharge at home for up to 2
weeks (HealthDot) or 3 weeks (Elan). Additionally, 20 patients of the 350 will
be recruited to wear the HealthDot (for up to 1 week) as well as the Elan (for
48 hours) for up to 1 week before surgery to get their baseline values on heart
rate and respiratory rate. The HealthDot will measure breast motion by
accelerometer and calculate heart rate, posture, activity and respiratory rate
which are stored on the device as well as sent via LoRa network to Philips. The
Elan device will measure PPG and accelerometer data which is transferred via a
MSX box to Philips.
Study burden and risks
For the patients participating in this investigation no benefits have been
identified. Potential chemical, electrical, biological hazards associated with
the devices as well as risks associated with the devices and their potential
interference with the clinical work flow have been identified, scored and if
needed mitigated (see Risk Management Plan and Risk Management Summary Matrix
of PJ-013483 FLAGSHIP Transitional Care Study 3). Though the patients undergo
surgery with the associated risks of this procedure this is not part of the
study and the study does not influence the surgery risks. The placement of the
devices will add some additional burden to the patient not related to her/his
stay in hospital, however this additional burden is low and the risks are
acceptable justifying the execution of the study.
High Tech Campus 11
Eindhoven 5656AE
NL
High Tech Campus 11
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
- Adult
- Willing and able to sign informed consent form
- Willingness to abstain from visiting a sauna during the study period
- Willingness to dry area where the HealthDot is applied in a dipping fashion
after washing
- Willingness to abstain from flying during the study period of time
- Elective surgery
- General anesthesia required for surgery
Exclusion criteria
- General inmates of psychiatric wards, 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 of investigation of both devices
- Pregnant, or breastfeeding
- Known to be allergic for the tissue adhesive used in the HealthDot.
- 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 implantables such as Implantable Cardioverter
Defibrilator (ICD) and pacemaker
- Unable to understand instructions
- Expected participation less than 2 weeks
- 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.
- Area on arm where the Elan device is applied is involved in the surgical
procedure.
- Patients with antibiotic resistant infections (e.g. MRSA).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68560.015.18 |