Photoplethysmography for Diagnose Incipient Hypovolemia

Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05512611

Enrollment

Registered

2022-08-23

Start date

2022-08-15

Completion date

2023-02-28

Last updated

2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

Keywords

Photoplethysmography, Vital signs, Hemodynamics

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 .

Interventions

DIAGNOSTIC_TESTFinger photoplethysmography

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026