Photoplethysmography for Diagnose Incipient Hypovolemia

February 28, 2023 updated by: Hospital Privado de Comunidad de Mar del Plata

Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Hospital Privado de Comunidad

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy blood donor volunteers.

Description

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Hospital Privado de Comunidad de Mar del Plata

Investigators

  • Study Chair: Gerardo Tusman, MD, Hospital Privado de Comunidad

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)

August 15, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2919-2809/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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