Systematic Calculation of HyperOxygenation Transit Time

Not Applicable

Terminated

• Conditions: Cardiac Output

• Registration Number: NCT04007146
• Lead Sponsor: University Hospital, Angers

Brief Summary

Cardiac output (CO) is an essential physiological parameter of healthy person or illness.

In clinical practices, all methods of measuring the CO(Fick method, thoracic impedance, esophageal echodoppler etc) contain limit. Each method are dangerous or hard to implement.

CO is probably determining element of blood transit time and thus the availability of oxygen between the central organs (heart, lung) and the peripheral organs (leg, arms).

Our hypothesis is transcutaneous oxymetry mesurement with oxygen inhalation, to cause a transient hyperoxia, can be used to determinate blood transit time between central organs and peripheral organs. This simple method will be non invasive technique.

Detailed Description

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.

The time of onset hyperoxia will be compare to usual CO method by cross correlation.

The duration of participation for subject is equal to 1 hour.

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2020-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Adults over 18
• Cardiac output measurement considered at least 2 hours prior to the study
• Affiliation to a French National healthcare system
• Written informed consent must be obtained prior to protocol-specific

Exclusion Criteria

• Acute or decompensated cardiac or respiratory failure
• Allergy to medical adhesives
• Patients under reinforced protection, pregnancy, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
• Inability to understand the instructions or objectives of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimation of transcutaneous oxymetry with transient hyperoxia	24 months	Transition time calcutation from oxygen to peripheral organs by transcutaneous oxymetry method.
Average of CO measured	24 months	Average of CO by usual method (catheterisation or transoesophageal echocardiography) reported in medical record of patients

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Angers, France