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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

Tracking Information
First Submitted Date  ICMJE October 13, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE September 15, 2015
Actual Primary Completion Date October 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02934308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
Official Title  ICMJE Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pain
Intervention  ICMJE Device: Skin Conductance Monitor
Other Name: monitors skin conductance values
Study Arms  ICMJE Experimental: ICU patients
Intervention: Device: Skin Conductance Monitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
67
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2016)
60
Actual Study Completion Date  ICMJE October 10, 2017
Actual Primary Completion Date October 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02934308
Other Study ID Numbers  ICMJE 2014-66
2014-A01770-47 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Fischler, MD, PhD Hôpital Foch
PRS Account Hopital Foch
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP