SepsisVIGRNCT01891253
Inert Gas Rebreathing in Ventilated Patients
An observational study of Sepsis and Respiratory Failure, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Respiratory Failure, Heart Failure
- What is being tested?
- non-invasive determination of cardiac output
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ventilated ICU patients
Who may be able to join
- age 18 - 80 years
- mechanically ventilated patient
- existing PiCCO arterial line
Who cannot join
- 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) ]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, Respiratory Failure, Heart Failure, Renal Failure
- Being tested
- non-invasive determination of cardiac output
- Keywords
- cardiac output, mechanical ventilation, inert gas rebreathing, pulse contour analysis
- Medical subject headings
- Sepsis, Respiratory Insufficiency, Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive determination of cardiac outputDevice
| Study group | Role | What they receive |
|---|---|---|
| ventilated patients | ventilated patients in an internal medicine ICU with existing PiCCO invasive hemodynamic monitoring Receives: Device: non-invasive determination of cardiac output |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
Determination of cardiac output using invasive pulse contour analysis (PiCCO) and non-invasive inert gas rebreathing (Innocor)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Saur, Universitätsmedizin Mannheim
- Investigators
- Joachim Saur, MD, Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891253
- Sponsor's protocol ID
- VIGR_MA
- Acronym
- VIGR
- Status last verified
- Sep 2019
- First submitted
- 20 Jun 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Non-invasive Determination of Cardiac Output Using Inert Gas Rebreathing in Ventilated Patients
- ClinicalTrials.gov ID
- NCT01891253
- Acronym / sponsor ID
- VIGR / VIGR_MA
- Conditions
- Sepsis, Respiratory Failure, Heart Failure, Renal Failure
- Keywords
- cardiac output, mechanical ventilation, inert gas rebreathing, pulse contour analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilated patients | – | Device: non-invasive determination of cardiac outputventilated patients in an internal medicine ICU with existing PiCCO invasive hemodynamic monitoring |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ventilated ICU patients
Key inclusion criteria (3 listed)
- age 18 - 80 years
- mechanically ventilated patient
- existing PiCCO arterial line
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive determination of cardiac output | Device | ventilated patients |
Primary outcome
cardiac output
Time frame: 1 day
Determination of cardiac output using invasive pulse contour analysis (PiCCO) and non-invasive inert gas rebreathing (Innocor)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Saur, MD principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Respiratory Failure, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac output (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.