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NCT03467230 · ClinicalTrials.gov registry record
Performance Assessment of the PMD-200 Under General Anesthesia
A clinical trial, sponsored by University of Vermont.
- Completed
- Registry status
- 61
- Enrollment target
NCT03467230: Completed study, sponsored by University of Vermont.
NCT03467230 is a clinical trial that has completed, run by University of Vermont. The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03467230 has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
Study Summary
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state. The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient. All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.
Primary Outcome
To demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration). Specifically, the investigators will assess the % change from baseline-steady state NoL Index value with the NoL Index value during surgical stimulation (increased noxious stimulation) as well as the NoL Index value after administration of
Interventions
- DEVICE NoL Index
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2018-12-12 |
What the finished NCT03467230 record still lists
NCT03467230 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which NoL Index is the first listed.
NCT03467230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03467230 about?
NCT03467230 is a clinical study titled "Performance Assessment of the PMD-200 Under General Anesthesia". A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state. The purpose of this project is to conduct an observational study...
What is the current status of trial NCT03467230?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2018-03-15. Estimated completion is 2018-12-12.
What interventions are being tested in trial NCT03467230?
The interventions under investigation include: NoL Index (DEVICE).
Who is sponsoring clinical trial NCT03467230?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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