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Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU

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ClinicalTrials.gov Identifier: NCT02276703
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : September 15, 2017
Sponsor:
Collaborators:
Med-Storm Innovation
Hopital Foch
Information provided by (Responsible Party):
Elizabeth H. Sinz, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date October 24, 2014
First Posted Date October 28, 2014
Last Update Posted Date September 15, 2017
Actual Study Start Date October 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2014)
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 Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU
Official Title 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 Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult Intensive Care Unit (ICU) patients between the ages of 18-89 years (inclusive), that are scheduled to receive a painful procedure. We are requesting a total population of 120 to allow for withdrawals
Condition Pain
Intervention Device: Skin Conductance Monitor
monitors skin conductance values
Other Name: Algesimeter
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: September 14, 2017)
30
Original Estimated Enrollment
 (submitted: October 24, 2014)
100
Actual Study Completion Date June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276703
Other Study ID Numbers STUDY00000725
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elizabeth H. Sinz, Milton S. Hershey Medical Center
Study Sponsor Milton S. Hershey Medical Center
Collaborators
  • Med-Storm Innovation
  • Hopital Foch
Investigators Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date September 2017