NCT03648853

Brief Summary

The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 30, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

August 24, 2018

Results QC Date

March 7, 2020

Last Update Submit

May 9, 2020

Conditions

Keywords

photoplethysmographystress response

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-2 minutes

Study Arms (1)

intervention

EXPERIMENTAL

all participants receive the same intervention

Device: Tetanic Stimulus

Interventions

5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical patients general anesthesia able to consent in english

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94122, United States

Location

Related Publications (1)

  • Talke P, Talke I. Effect of the Location of Tetanic Stimulation on Autonomic Responses: A Randomized Cross-Over Pilot Study. J Pain Res. 2024 Jan 9;17:209-217. doi: 10.2147/JPR.S443058. eCollection 2024.

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Results Point of Contact

Title
Pekka Talke
Organization
UCalifornia San Francisco

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 24, 2018

First Posted

August 27, 2018

Study Start

September 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

May 22, 2020

Results First Posted

April 30, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations