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Non-invasive Pain Monitoring in Post-operative Patients

NCT03832764 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2019-02-06

No results posted yet for this study

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

DEVICE

ANSPEC-PRO

Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • University Ghent

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-06-26
Completion
2018-06-26

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832764 on ClinicalTrials.gov