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Effect of Location of Tetanic Stimuli on Photoplethysmogram

Primary Purpose

Stress Reaction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetanic Stimulus
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Reaction focused on measuring photoplethysmography, stress response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Surgical patients general anesthesia able to consent in english

Exclusion Criteria:

  • regional anesthesia unable to consent in english under 18 yrs of age

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

all participants receive the same intervention

Outcomes

Primary Outcome Measures

Photoplethysmography (PPG)
Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2018
Last Updated
May 9, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03648853
Brief Title
Effect of Location of Tetanic Stimuli on Photoplethysmogram
Official Title
Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.
Detailed Description
A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction
Keywords
photoplethysmography, stress response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
all participants receive the same intervention
Intervention Type
Device
Intervention Name(s)
Tetanic Stimulus
Intervention Description
5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order
Primary Outcome Measure Information:
Title
Photoplethysmography (PPG)
Description
Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is.
Time Frame
1-2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgical patients general anesthesia able to consent in english Exclusion Criteria: regional anesthesia unable to consent in english under 18 yrs of age
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Location of Tetanic Stimuli on Photoplethysmogram

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