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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
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
Pain in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales.When a patient is unable to communicate, a method that would allow the caregiver to continuously monitor patients' pain and alert the provider that the patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing changes in skin conductance that can be used in patients who are unable to provide a subjective pain score. This study will compare the relationship between the measurements taken by the PainMonitor and pain scores given by communicative patients to evaluate the safety and efficacy of this monitor during planned, routine procedures.

Condition or disease Intervention/treatment Phase
Pain Device: Skin Conductance Monitor Not Applicable

Detailed Description:

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
  • pupillometry
  • EEG
  • 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: ICU patients Device: Skin Conductance Monitor
Other Name: monitors skin conductance values




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 18-89 years (inclusive), in an adult ICU
  • Patients admitted to the ICU who are able to communicate their pain and anxiety using a VAS
  • Patients must be cooperative and not agitated.
  • Planned to have a potentially painful procedure

Exclusion Criteria:

  • Diagnosed neuropathic disease
  • Use of neostigmine within the past 3 hours
  • Use of regional anesthesia at the extremity where the device electrodes are placed -

Information from the National Library of Medicine

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


Locations
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France
Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Marc Fischler, MD, PhD Hôpital Foch

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02934308     History of Changes
Other Study ID Numbers: 2014-66
2014-A01770-47 ( Other Identifier: ANSM )
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No