Photoplethysmography for Diagnose Incipient Hypovolemia

• Sponsor: Hospital Privado de Comunidad de Mar del Plata (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05512611
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Days): 26
• Patients Per Site Per Month: 70.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia	Diagnostic Test: Finger photoplethysmography

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers
• Actual Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 10, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. Analysis of non-invasive arterial blood pressure (NIBP) [15 minutes]

   NIBP is recorded in mmHg. This information is analyzed before and after blood donation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Privado de Comunidad	Mar del Plata	Buenos Aires	Argentina	7600

Sponsors and Collaborators

• Hospital Privado de Comunidad de Mar del Plata

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Privado de Comunidad de Mar del Plata
• ClinicalTrials.gov Identifier: NCT05512611
• Other Study ID Numbers: 2919-2809/2022
• First Posted: Aug 23, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Privado de Comunidad de Mar del Plata: Photoplethysmography; Vital signs; Hemodynamics
• Additional relevant MeSH terms: Hypovolemia

Study Results

No Results Posted as of Aug 23, 2022