NCT03832764

Non-invasive Pain Monitoring in Post-operative Patients

Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

During the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). The measurement is done using standard ECG electrodes placed in the hand palm of the patient. The patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. As a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the MedStorm device. The study will try to answer the following questions: * Are the measurements with the ANSPEC-PRO correlated with the NRS values? * What is the (mathematical) relationship between the measured values and the NRS? * Is there difference between the two devices in measuring pain levels? And what is this difference if pain alleviation medication is given to the patient? * A number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	ANSPEC-PRO	Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU

Timeline

• Start date: 2018-05-01
• Primary completion: 2018-06-26
• Completion: 2018-06-26
• First posted: 2019-02-06
• Last updated: 2019-02-06

Locations

1 site across 1 country: Belgium