Perfusion Index in Anesthesia | NCT02989441

Studies
Perfusion Index in Anesthesia

NCT02989441

Sponsor

Jakob Højlund

Status

Completed

Last Update Posted

Aug 17, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Monitoring, Physiological

Interventions

Not provided

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

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

Nov 2016Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Dec 7, 2016

First Submission Date that Met QC Criteria

Dec 9, 2016

First Posted Date

Dec 12, 2016Estimated

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

Aug 16, 2018

Last Update Posted Date

Aug 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)

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

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)		Intra-operative

Secondary Outcomes

Measure	Description	Time Frame
Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)		Intra-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
Willingness to participate

Exclusion Criteria:

Patient refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients for elective and sub-acute surgical repair of para-oesophagal hernia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolai B Foss, MD PhD	Hvidovre University Hospital, University of Copenhagen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Hvidovre	Capital Region	DK-2650	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 29, 2021
Reset	Mar 11, 2022

Submission Tracking

Estimated Results First Submitted Date

Dec 29, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 29, 2021			Mar 11, 2022