Response of the heart and blood vessels on different concentrations of oxygen

The cardiovascular dose-response to supplemental oxygen in healthy volunteers - DRO2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002342-23-NL

Enrollment

Unknown

Registered

2016-07-01

Start date

2016-07-29

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy cardiovascular system

Interventions

Trade Name: Conoxia Product Name: Conoxia Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy 18-55 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Active smoking - Diagnosed lung pathology (which requires medication or impedes exercise) - Diagnosed left-right shunt - Diagnosed cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the dose-response relationship between PaO2 and sublingual microcirculatory perfusion.;Secondary Objective: To explore the dose-response relationship between PaO2 and systemic hemodynamics;Primary end point(s): The main study parameter is the change in perfused vessel density (PVD) of small vessels (<20 µm), as measured by sublingual sidestream darkfield imaging;Timepoint(s) of evaluation of this end point: After 10 minutes of supplemental oxygen breathing	—

Measure

Time frame

Main Objective: To explore the dose-response relationship between PaO2 and sublingual microcirculatory perfusion.;Secondary Objective: To explore the dose-response relationship between PaO2 and systemic hemodynamics;Primary end point(s): The main study parameter is the change in perfused vessel density (PVD) of small vessels (<20 µm), as measured by sublingual sidestream darkfield imaging;Timepoint(s) of evaluation of this end point: After 10 minutes of supplemental oxygen breathing

—

Secondary

Measure	Time frame
Secondary end point(s): - Cardiac Output - Systemic Vascular Resistance - Heart Rate - Mean Arterial Pressure ;Timepoint(s) of evaluation of this end point: After 10 minutes of supplemental oxygen breathing	—

Countries

Netherlands

Contacts

Public ContactDepartmen of Intensive Care

VU University Medical Center

b.smit@vumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026