HypovolemiaNCT05512611
Photoplethysmography for Diagnose Incipient Hypovolemia
An observational study of Hypovolemia, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Finger photoplethysmography
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Aug 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy blood donor volunteers.
Who may be able to join
- Written Inform Consent
- weight > 50 kg,
- hemoglobin >12.5 gr/dl
Who cannot join
- pregnancy,
- ≤ 12 months from delivery or abortion,
- symptoms of allergy,
- fever >37 °C,
- infectious diseases,
- addictions,
- volunteers that received previous blood transfusions
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers
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.
Read the 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 .
- Conditions
- Hypovolemia
- Being tested
- Finger photoplethysmography
- Keywords
- Photoplethysmography, Vital signs, Hemodynamics
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger photoplethysmographyDiagnostic test
Finger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the continuous component (DC) of the photoplethysmography signal.
The DC components of photoplethysmography is measured in arbitrary units (a.u).
Measured: 15 minutes
Secondary outcomes (1)
Analysis of non-invasive arterial blood pressure (NIBP)
NIBP is recorded in mmHg. This information is analyzed before and after blood donation.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Tusman, MD, Study chair, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512611
- Sponsor's protocol ID
- 2919-2809/2022
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers
- ClinicalTrials.gov ID
- NCT05512611
- Acronym / sponsor ID
- 2919-2809/2022
- Conditions
- Hypovolemia
- Keywords
- Photoplethysmography, Vital signs, Hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy blood donor volunteers.
Key inclusion criteria (3 listed)
- Written Inform Consent
- weight > 50 kg,
- hemoglobin >12.5 gr/dl
Key exclusion criteria (7 listed)
- pregnancy,
- ≤ 12 months from delivery or abortion,
- symptoms of allergy,
- fever >37 °C,
- infectious diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger photoplethysmographyFinger photoplethysmography in tested hand, noninvasive blood pressure and heart rate during blood donation. | Diagnostic test | – |
Primary outcome
Analysis of the continuous component (DC) of the photoplethysmography signal.
Time frame: 15 minutes
The DC components of photoplethysmography is measured in arbitrary units (a.u).
1 secondary outcome
Analysis of non-invasive arterial blood pressure (NIBP)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerardo Tusman, MD study chair
Hospital Privado de Comunidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the continuous component (DC) of the photoplethysmography signal. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.