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

NCT02276703 | Completed

• 1 other identifier: STUDY00000725
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity with a confidence interval

  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.

  1 year

Interventions

Skin Conductance Monitor DEVICE

monitors skin conductance values

Also known as: Algesimeter

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Med-Storm Innovation: collaborator
• Hopital Foch: collaborator

Study Sites (2)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1)