NCT05512611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 1, 2023

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

April 12, 2022

Last Update Submit

February 28, 2023

Conditions

Hypovolemia

Keywords

PhotoplethysmographyVital signsHemodynamics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Analysis of non-invasive arterial blood pressure (NIBP)

    15 minutes

Interventions

Finger photoplethysmographyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy blood donor volunteers.

You may qualify if:

  • Written Inform Consent
  • weight \> 50 kg,
  • hemoglobin \>12.5 gr/dl

You may not qualify if:

  • pregnancy,
  • ≤ 12 months from delivery or abortion,
  • symptoms of allergy,
  • fever \>37 °C,
  • infectious diseases,
  • addictions,
  • volunteers that received previous blood transfusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

August 23, 2022

Study Start

August 15, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 1, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)