The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

NCT06117111 | Completed

• 1 other identifier: PAMO2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Signs

Keywords

vital signs; intraoperative monitoring

Outcome Measures

Primary Outcomes (3)

• Electrocardiography (ECG)

  Mean error an mean absolute error between the study device and standard monitor heart rae

  Continuous measurement 24 hours

• Plethysmography

  Mean error and mean absolute error between the study monitor and standard monitor

  Continuous measurement 24 hours

• Respiration rate

  Mean error and mean absolute error between the study monitor and standard monitor

  Continuous measurement 24 hours

Secondary Outcomes (2)

• usability

  Continuous measurement 24 hours

• blood pressure

  Continuous measurement 24 hours

Study Arms (1)

Study group

Age: minimum of 18 years, Undergoing pancreatic or ENT tumour surgery, Ability to give informed consent, Volunteering to the study. Monitored in addition to standard monitoring using PaMo device.

Device: PaMo monitoring device

Interventions

PaMo monitoring device DEVICE

Comparison of the device to standard monitoring

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Study Officials

• Jarkko Harju

  Deputy chief physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: November 3, 2023
• Study Start: December 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)