Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 1:41 AM
Study NCT ID:
NCT01631695
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Medasense Pain Monitor Performances
Sponsor:
Medasense Biometrics Ltd
Organization:
Study Overview
Official Title:
Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.
Detailed Description:
Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the visual analog scale (VAS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.
In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 0281-09-RMB | OTHER | Rambam Health Care Campus, Haifa, Israel | View |