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

NCT02934308 | Completed

• 2 other identifiers: 2014-662014-A01770-47
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Study Arms (1)

ICU patients

EXPERIMENTAL

Device: Skin Conductance Monitor

Interventions

Skin Conductance Monitor DEVICE

Also known as: monitors skin conductance values

ICU patients

Eligibility Criteria

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

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

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Fischler, MD, PhD

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: September 15, 2015
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)