Clinical trial NCT06117111: The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
Official title: The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Signs
Keywords: vital signs
intraoperative monitoring
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2023-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main study population is formed by adult patients entering to pancreatic or ear tumour surgery following postoperative intensive care treatment.

Brief summary: This clinical investigation assesses the performance of PaMo patient monitor system (PaMo) and its wearable sensing devices that combines continuous IP, ECG and PPG in detecting developing respiratory depression episodes. PaMo patient monitor system consists of a wearable measurement unit worn on a patient, bedside mobile unit that receives the data from the wearable unit through Bluetooth Low Energy connection, visualises it, and can be relayed further to the central unit through WiFi network.

Detailed description: Monitoring of voluntary subjects undergoing major surgery requiring postoperative intensive care treatment with PaMo patient monitoring device that includes continuous ECG, respiration and PPG monitoring.

The monitoring device is connected during anaesthesia preparation before induction of general anaesthesia and monitoring is continued throughout the surgery and in the intensive care unit (ICU) for total of 24 hours. For reference data, GE Carescape B850 patient monitors are used continuously for oxygen saturation, ECG and respiration signals. The data are collected from the reference patient monitor using a S/5 collect software and a study computer. In addition, to obtain a gold standard reference for SpO2 with blood gas analyzer arterial samples are taken every two hours during anesthesia and in the ICU concurrently with the routine checkups. During the surgery, an arterial cannula collects continuous blood pressure data and can be used for taking blood samples. The data collected with PaMo device and reference monitor are analyzed in Tampere University by researchers and used in device, software and algorithm development.

User experience information and usability feedback are collected at the end of the study from the medical staff with an interview form.

The study does not include a control group. All subjects are using the devices in similar way and the parameters collected from the same individual using two different methods are compared.

Eligibility criteria: Inclusion Criteria:

* Age: minimum of 18 years
* Undergoing pancreatic or ENT tumour surgery
* Ability to give informed consent
* Volunteering to the study

Exclusion Criteria:

* Age under 18 years
* Insufficient knowledge in Finnish
* Cardiac pacemaker
* Inability to give informed consent
* Denial

Primary outcomes:
measure: Electrocardiography (ECG)
timeFrame: Continuous measurement 24 hours
measure: Plethysmography
timeFrame: Continuous measurement 24 hours
measure: Respiration rate
timeFrame: Continuous measurement 24 hours
Secondary outcomes:
measure: usability
timeFrame: Continuous measurement 24 hours
measure: blood pressure
timeFrame: Continuous measurement 24 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Deputy chief physician
name: Jarkko Harju
role: PRINCIPAL_INVESTIGATOR
References: