Critical IllnesshDOS-CONCT07298720
Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
An observational study of Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Passive Leg Raising maneuver
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients with their blood pressure invasively monitored through an arterial line
Who may be able to join
- Invasive blood pressure monitoring through an arterial line
Who cannot join
- Patients with suspected pregnancy
- Intra-abdominal hypertension
- Elevated intracranial pressure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Parc Taulí Hospital Universitari
Sabadell, Spain/ Barcelona, 08208
Jaume Mesquida Senior Clinical Researcher, MD, +34 616722287, jmesquida@tauli.cat
About this study
Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase > 10%) will be assessed.
- Conditions
- Critical Illness
- Being tested
- Passive Leg Raising maneuver
- Keywords
- Fluid-responsiveness, Hemodynamic monitoring, Preload-responsiveness, Cardiac output
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg Raising maneuverOther
The PLR will be performed using automatic bed adjustment: Starting from a semi-recumbent position, the lower limbs will be elevated to a 45° angle while the trunk will be moved from semi-recumbent to supine. After three minutes, subjects will be returned to the initial semi-recumbent position.
| Study group | Role | What they receive |
|---|---|---|
| Critical care patient | Critical care patients with their blood pressure invasively monitored through an arterial line Receives: Other: Passive Leg Raising maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output Response
The relative increase in % of the Cardiac Output (CO), from baseline during the Passive Leg Raising (PLR) test (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start7 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO)
- Responsible party
- Principal investigator, Jaume Mesquida, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298720
- Sponsor's protocol ID
- CEIm 2024/3001
- Other IDs
- INN2024003, CIR2023014
- Acronym
- hDOS-CO
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
- ClinicalTrials.gov ID
- NCT07298720
- Acronym / sponsor ID
- hDOS-CO / CEIm 2024/3001
- Conditions
- Critical Illness
- Keywords
- Fluid-responsiveness, Hemodynamic monitoring, Preload-responsiveness, Cardiac output
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase > 10%) will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical care patient | – | Other: Passive Leg Raising maneuverCritical care patients with their blood pressure invasively monitored through an arterial line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with their blood pressure invasively monitored through an arterial line
Key inclusion criteria (1 listed)
- Invasive blood pressure monitoring through an arterial line
Key exclusion criteria (3 listed)
- Patients with suspected pregnancy
- Intra-abdominal hypertension
- Elevated intracranial pressure
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 |
|---|---|---|
| Passive Leg Raising maneuverThe PLR will be performed using automatic bed adjustment: Starting from a semi-recumbent position, the lower limbs will be elevated to a 45° angle while the trunk will be moved from semi-recumbent to supine. After three minutes, subjects will be returned to the initial semi-recumbent position. | Other | Critical care patient |
Primary outcome
Cardiac Output Response
Time frame: During procedure
The relative increase in % of the Cardiac Output (CO), from baseline during the Passive Leg Raising (PLR) test (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaume Mesquida Senior Clinical Researcher, MD (+34 616722287, jmesquida@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output Response (time frame: During procedure). 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 18 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.