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Systematic Calculation of HyperOxygenation Transit Time

NCT ID: NCT04007146

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Cardiac Output

Keywords

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Cardiac Output vascular medicine Transcutaneous Oxymetry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cardiac Output Measurement

Subject will have a usual cardiac output

Group Type EXPERIMENTAL

Transcutaneous oxymetry measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Transcutaneous oxymetry measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre MD ABRAHAM, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Angers

Locations

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Centre hospitalier universitaire

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2019-002571-33

Identifier Type: -

Identifier Source: org_study_id