Systematic Calculation of HyperOxygenation Transit Time

NCT04007146 | Terminated DMC

• 1 other identifier: 2019-002571-33
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output

Keywords

Cardiac Output; vascular medicine; Transcutaneous Oxymetry

Outcome Measures

Primary Outcomes (2)

• Estimation of transcutaneous oxymetry with transient hyperoxia

  Transition time calcutation from oxygen to peripheral organs by transcutaneous oxymetry method.

  24 months

• Average of CO measured

  Average of CO by usual method (catheterisation or transoesophageal echocardiography) reported in medical record of patients

  24 months

Study Arms (1)

Cardiac Output Measurement

EXPERIMENTAL

Subject will have a usual cardiac output

Diagnostic Test: Transcutaneous oxymetry measurement

Interventions

Transcutaneous oxymetry measurement DIAGNOSTIC_TEST

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

Cardiac Output Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

Study Officials

• Pierre MD ABRAHAM, PhD

  University Hospital in Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: March 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)