Systematic Calculation of HyperOxygenation Transit Time

Cardiac Output Clinical Trial

— SCHOTT  

Official title:

Systematic Calculation of HyperOxygenation Transit Time Mesure transcutanée de l'oxygène au Cours de l'Hyperoxie Transitoire

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04007146
• Other study ID #: 2019-002571-33
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Diagnostic Test:
• Transcutaneous oxymetry measurement
Transcutaneous oxymetry measurement with transient hyperoxia period (2 periods of 30seconds at 60% of oxygen)

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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