Photoplethysmography for Diagnose Incipient Hypovolemia

Hypovolemia Clinical Trial

Official title:

Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512611
• Other study ID #: 2919-2809/2022
• Status: Completed
• Start date: August 15, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2022
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Diagnostic Test:
• Finger photoplethysmography
Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Mar del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome

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