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Completed

NCT Number: NCT05512611

Photoplethysmography for Diagnose Incipient Hypovolemia

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.

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Key information

Conditions

Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finger photoplethysmography

Diagnostic Test

Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Official study title

Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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