The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph

January 25, 2017 updated by: Pekka Talke, University of California, San Francisco

The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography

Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective, healthy surgical patients over 18 yrs of age

Description

Inclusion Criteria:

  • Elective surgery
  • General endotracheal anesthesia
  • Over 18 years of age
  • Healthy

Exclusion Criteria:

  • Vascular disease
  • Liver or kidney disease
  • Overweight

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photoplethysmography
Time Frame: within 60 seconds of intubation
changes in AC and DC components of photoplethysmography
within 60 seconds of intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse rate
Time Frame: within 60 seconds of intubation
Pulse rate from photoplethysmograph
within 60 seconds of intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Pekka O Talke, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2007

Primary Completion (Actual)

January 30, 2012

Study Completion (Actual)

January 30, 2015

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PT071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

only a unique study number such as, IP01, that is unrelated to any patient identifiers will be used

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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