Inert Gas Rebreathing in Ventilated Patients (VIGR)

September 24, 2019 updated by: Joachim Saur, Universitätsmedizin Mannheim

Feasibility of the Non-invasive Determination of Cardiac Output Using Inert Gas Rebreathing in Ventilated Patients

Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Germany
    • Baden-Württemberg
      • Manheim, Baden-Württemberg, Germany, 68167
        • Universitätsmedizin Mannheim

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ventilated ICU patients

Description

Inclusion Criteria:

  • age 18 - 80 years
  • mechanically ventilated patient
  • existing PiCCO arterial line

Exclusion Criteria:

  • FiO2 > 60% (fraction of inspired oxygen)
  • PEEP > 10 mmHg (positive end-expiratory pressure)
  • SO2 < 90% (oxygen saturation )
  • Systolic blood pressure < 90 mmHg
  • Heart rate > 150 bpm
  • APRV (airway pressure release ventilation)
  • ICD (implantable cardioverter defibrillator) / pace maker
  • [ Anaesthetic Conserving Device (Anaconda) ]

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ventilated patients
ventilated patients in an internal medicine ICU with existing PiCCO invasive hemodynamic monitoring
Device: non-invasive determination of cardiac output

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac output
Time Frame: 1 day
Determination of cardiac output using invasive pulse contour analysis (PiCCO) and non-invasive inert gas rebreathing (Innocor)
1 day

Collaborators and Investigators

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

Sponsor

Universitätsmedizin Mannheim

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, 2013

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (ESTIMATE)

July 3, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIGR_MA

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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