The Effect of Tracheal Intubation on AC and DC Components... | NCT03032939

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

NCT03032939

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Jan 26, 2017Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Anesthesia Intubation Complication

Interventions

endotracheal intubation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2007Actual

Primary Completion Date

Jan 30, 2012Actual

Completion Date

Jan 30, 2015Actual

First Submitted Date

Jan 24, 2017

First Submission Date that Met QC Criteria

Jan 25, 2017

First Posted Date

Jan 26, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pekka Talke, Professor of Anesthesia, University of California, San FranciscoPrincipal Investigator

Lead Sponsor

University of California, San FranciscoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endotracheal intubation	Procedure	standard endotracheal intubation of surgical patients after induction of anesthesia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective surgery
General endotracheal anesthesia
Over 18 years of age
Healthy

Exclusion Criteria:

Vascular disease
Liver or kidney disease
Overweight

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Elective, healthy surgical patients over 18 yrs of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pekka O Talke, MD	University of California, San Francisco	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28469670	Derived	Talke P. The Effect of Tracheal Intubation-Induced Autonomic Response on Photoplethysmography. Anesthesiol Res Pract. 2017;2017:7646541. doi: 10.1155/2017/7646541. Epub 2017 Apr 2.

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques