Transcutaneous measurement of oxygen during transient hyperoxia
Phase 1
- Conditions
- Any patient with a cardiac output measurementTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2019-002571-33-FR
- Lead Sponsor
- CHU Angers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- Adults
- Social security
- written informed consent
- cardiac output measurementscheduled within 2 hours
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- Refusal to consent
- Adult patient protected under the law (guardianship)
- Pregnancy or breast-feeding women
- Patients unable to understand study procedures
- Subjects suffering from acute or decompensated heart or respiratory failure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the concordance between the simultaneous measurements of cardiac output measured by echocardiography-Transthoracic doppler or catheterization and response to transient inhalation of oxygen-enriched air in subjects with a cardiac output measurement in their management (assessment in the athlete or in the patient).;Secondary Objective: Not applicable;Primary end point(s): the temporal difference (mean phase shift) in observed responses from transcutaneous TcpO2 in the chest and periphery after two periods of inhalation of oxygen-enriched air (FiO2 ~ 60%) for 30 seconds separated by 5 minutes;Timepoint(s) of evaluation of this end point: 30 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable