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

• ClinicalTrials.gov Identifier: NCT02276703
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: September 15, 2017
• Sponsor: Milton S. Hershey Medical Center
• 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
• 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

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

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