Photoplethysmography for Diagnose Incipient Hypovolemia | NCT05512611

Studies
Photoplethysmography for Diagnose Incipient Hypovolemia

NCT05512611

Sponsor

Hospital Privado de Comunidad de Mar del Plata

Status

Completed

Last Update Posted

Mar 1, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Hypovolemia

Interventions

Finger photoplethysmography

Countries

Argentina

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

Mar 2022

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

Aug 15, 2022Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Feb 28, 2023Actual

First Submitted Date

Apr 12, 2022

First Submission Date that Met QC Criteria

Aug 22, 2022

First Posted Date

Aug 23, 2022Actual

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

Feb 28, 2023

Last Update Posted Date

Mar 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Hypovolemia caused by acute bleeding increased morbi-mortality in emergency and operatin rooms. Precise real-time diagnosis of incipient acute hypovolemia is lacking at the bedside. We hypothesize that the infrared-red signals of pulse oximetry are sensitive to acute changes in patient's volemia. We aimed to test this hypothesis in a cohort of healthy blood donors as a model of simulated acute hypovolemia.

Detailed Description

This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform can detect incipient hypovolemia. The investigators will studied 60 blood donor volunteers as a model of slight hypovolemia (8-10% of the volemia). Vital signs and photoplethysmography will be recorded in the thumb of the tested hand during a standard blood donation protocol. Recorded data will be analyzed and compared before and after blood donation .

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

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finger photoplethysmography	Diagnostic Test	Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of the continuous component (DC) of the photoplethysmography signal.	The DC components of photoplethysmography is measured in arbitrary units (a.u).	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Analysis of non-invasive arterial blood pressure (NIBP)	NIBP is recorded in mmHg. This information is analyzed before and after blood donation.	15 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written Inform Consent
weight > 50 kg,
hemoglobin >12.5 gr/dl

Exclusion Criteria:

pregnancy,
≤ 12 months from delivery or abortion,
symptoms of allergy,
fever >37 °C,
infectious diseases,
addictions,
volunteers that received previous blood transfusions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy blood donor volunteers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerardo Tusman, MD	Hospital Privado de Comunidad	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Privado de Comunidad		Mar del Plata	Buenos Aires	7600	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020896	Hypovolemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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