Photoplethysmography for Diagnose Incipient Hypovolemia

Completed

• Conditions: Hypovolemia

• Registration Number: NCT05512611
• Lead Sponsor: Hospital Privado de Comunidad de Mar del Plata

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 .

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-04-12
• Study Start: 2022-08-15
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Privado de Comunidad; 🇦🇷 Mar del Plata, Buenos Aires, Argentina