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We are conducting a study to evaluate two investigational devices that may help us better monitor discomfort or pain in anesthetized patients during minimally invasive lung surgery. We want to collect information on how people respond to pain related to their surgery. Currently, we use blood pressure (BP) and heart rate (HR) to check the response to pain. In this study, we will also use two devices called the Medasense PMD-100 and PhysioDoloris monitors to look at measurements of pain. We will compare the measurements from the study devices to the measurements of heart rate and blood pressure. We hope to enroll about 40 subjects in this study at the University of Washington Medical Center.
The following measurements will be collected during surgery for this research study.
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| Measure | Description | Time Frame |
|---|---|---|
| Nociception Level (NoL) index | The primary objective of this study is to measure the NoL index in patients having minimally invasive lung surgery and compare it to Analgesia Nociception index (ANI), HR and BP as indicators of pain | 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia nociception index (ANI) | The secondary objective of this study is to measure the ANI in patients having minimally invasive lung surgery and compare it to NoL index, HR and BP as indicators of pain | 5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia |
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Inclusion Criteria:
Exclusion criteria:
Non-inclusion criteria:
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Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Srdjan Jelacic, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23835792 | Background | Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9. | |
| 21095676 | Background | Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2015 | |
| Reset | Jan 12, 2016 | |
| Release | May 4, 2017 | |
| Reset | Oct 5, 2017 | |
| Release | Jun 12, 2018 | |
| Reset | Dec 28, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2015 | Jan 12, 2016 | |||
| May 4, 2017 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 30026938 | Derived | Bollag L, Jelacic S, Delgado Upegui C, Wu C, Richebe P. The nociception level index (NOL) response to intubation and incision in patients undergoing video-assisted thoracoscopic surgery (VATS) with and without thoracic epidural analgesia. A pilot study. F1000Res. 2018 Jun 22;7:875. doi: 10.12688/f1000research.15279.1. eCollection 2018. |
| Oct 5, 2017 |
| Jun 12, 2018 | Dec 28, 2018 |