Clara Ionescu
Ghent, Oost-Vlaanderen, 9000, Belgium
NCT Number: NCT03832764
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.
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Notify Me18 year–70 year
All sexes
Observational
Ghent, Oost-Vlaanderen, 9000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
Other names: MEDSTORM
Time frame: 140 minutes each patient
Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.
University Ghent
Other
Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients
Acronym: ANSPEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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