Systematic Calculation of HyperOxygenation Transit Time (SCHOTT)

November 25, 2021 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Output Measurement
Subject will have a usual cardiac output
Diagnostic test: Transcutaneous oxymetry measurement
Transcutaneous oxymetry measurement with transient hyperoxia period (2 periods of 30seconds at 60% of oxygen)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre MD ABRAHAM, PhD, University Hospital in Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-002571-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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