NCT01978379

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

October 25, 2013

Last Update Submit

August 12, 2014

Conditions

Pain

Keywords

General AnesthesiaNociception Level

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Analgesia nociception index (ANI)

    5 minutes prior to intubation until 5 minutes after the incision for patients undergoing minimally invasive lung surgery under general anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective Video-Assisted Thoracoscopic Surgery at University of Washington Medical Center

You may qualify if:

  • Patients who clinically consent to elective VATS procedure under general anesthesia,
  • Ages between 18 and 80 years,
  • Able to provide informed consent,
  • English speaking

You may not qualify if:

  • violation of protocol (e.g., administration of medication that does not comply with the study protocol or inability to measure NoL or ANI index)
  • subject has change of mind
  • surgery has to be repeated.
  • subject refusal
  • non-English speaking
  • previous chronic or neuropathic pain
  • previous chronic use of opioids
  • history of psychiatric disorder
  • previous ipsilateral thoracotomy or VATS
  • morbidly obese with body mass index \> 40
  • chronically treated with beta-blockers
  • unable to provide informed consent (we will not enroll subjects that require LAR consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23835792BACKGROUND

  • 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.

    PMID: 21095676BACKGROUND

  • 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.

    PMID: 30026938DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Srdjan Jelacic, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting Assistant Professor

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

US(1)