Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU (ICUPAIN)
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|ClinicalTrials.gov Identifier: NCT02934308|
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Skin Conductance Monitor||Not Applicable|
Although pain must be assessed to be treated, it has been challenging to obtain consistent, objective, and quantifiable measurements. The best methods currently available are subjective scales communicated by the patient such as standardized sentences, visual analog scales (VAS), or plain numeric scales. When a patient is unable to communicate, methods used to monitor pain are inadequate. A device that provides an objective assessment of pain in these patients would alert the patient's caregivers that the patient may be in pain and analgesic treatment is indicated.
Various methods (Evans et al, 2013; Kantor, 2014; Isnardon, 2013) have been proposed to monitor patients' reactions to nociceptive stimulation such as:
- changes in heart rate or blood pressure
- changes in microcirculation
- Auditory or somatosensory evoked potentials All of these methods have been found lacking, mostly due to a lack of specificity for pain. Pupillometry is not suitable for long periods of measurement and is sensitive to concomitant treatment (e.g. opioids).
Galvanometry has the potential to provide specific information related to pain in patients who are unable to communicate.
Since sweat glands are the only organs controlled solely by the sympathetic nervous system, there is a reasonable chance that the use of galvanometry can provide a reliable means of assessing pain. There are numerous papers on this topic; searching in PUBmed on the key words "pain" and "skin conductance" results in more than 250 papers (selected references are included in the list below). The PainMonitor system uses galvanometry to monitor changes in skin conductance responses per sec mirroring the number of bursts in the skin sympathetic nerves. This creates a warning for caregivers to assess the potential that the patient is in pain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU|
|Actual Study Start Date :||September 15, 2015|
|Actual Primary Completion Date :||October 10, 2017|
|Actual Study Completion Date :||October 10, 2017|
|Experimental: ICU patients||
Device: Skin Conductance Monitor
Other Name: monitors skin conductance values
- Sensitivity and specificity with a confidence interval [ Time Frame: 1 year ]Sensitivity and specificity with a confidence interval > 80 % when skin conductance responses per sec are > 0.13 and VAS is equal to or greater than 30 mm. This end point will be reached by 100 patients with at least 10 discrete measurements for each patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934308
|Suresnes, France, 92150|
|Principal Investigator:||Marc Fischler, MD, PhD||Hôpital Foch|