Sinus RhythmTPTD-TTE-SRNCT04637126
Cardiac Output Monitoring by Transpulmonary Thermodilution and Transthoracic Echocardiography in Critically Ill Patients
An observational study of Sinus Rhythm, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. The two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Rhythm
- What is being tested?
- Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2020to 10 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients requiring hemodynamic assessment
Who may be able to join
- mechanically ventilated and sedated patients
- with sinus rhythm
- hospitalized in Intensive Care Unit
- fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure
Who cannot join
- age under 18
- arrhythmia
- severe aortic regurgitation or stenosis
- intracardiac shunt
- poor echogenicity
- tamponade
- major subject to a legal protection regim.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Output Measurement in Critically Ill Patient in Sinus Rhythm: a Comparison Between Transpulmonary Thermodilution and Transthoracic Echocardiography
Cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. The two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. The objective of this study is to compare accuracy and trending ability of CO measurement by TPTD and TTE in critically ill patients with sinus rhythm.
Read the detailed description
TTE is an easy noninvasive device now recommended as the first evaluation of the patient in circulatory failure but it present some limits due to poor echogenicity of patients, operator-dependent variability and cannot provide continuous hemodynamic data. TPTD is an invasive technique for CO monitoring recommended especially in shock not responsive to initial therapy.
Few studies have evaluated the level of agreement of each method (TTE and TPTD) with the reference method (pulmonary artery catheter) but they have never been compared between them with strong statistical analysis in particular trending ability.
It could be interesting to determine the level of concordance of these two methods of CO monitoring and trend ability by TPTD relative to TTE.
The investigators hypothesize that CO-TPTD are concordant with those performed by TTE.
Mechanically ventilated patients requiring hemodynamic assessment will be included. CO-TPTD will be measured via intermittent thermodilution. Blindly, a second investigator will use standard-view TTE to estimate CO-TTE as the product of stroke volume and the heart rate obtained during the measurement the blood flow velocity (using a Doppler technique) at the left ventricular outflow tract. A second measurement will be done with the two devices after a fluid challenge when patient requires it to compare trending ability.
- Conditions
- Sinus Rhythm
- Being tested
- Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography
- Keywords
- Cardiac output monitoring, Transthoracic echocardiography, Transpulmonary thermodilution, Intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiographyOther
Cardiac output is measured for all patients with transpulmonary thermodilution TPTD and transthoracic echocardiography TTE according to the recommendations
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated and sedated patients with sinus rhythm | all mechanically ventilated and sedated patients with sinus rhythm hospitalized in our ICU and fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure Receives: Other: Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
bias between cardiac output measurement by TPTD and by TTE
bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
Measured: Day 0
Secondary outcomes (3)
percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
Measured: Day 0
percentage error between the value of Cardiac Output measured with TTE (transthoracic echocardiography) and the value of Cardiac Output measured withTPTD (transpulmonary thermodilution) after a fluid challenge.
percentage error between the value of Cardiac Output measured with TTE and the value of Cardiac Output measured withTPTD after a fluid challenge.
Measured: 15 minutes after inclusion
The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)
The ability of TPTD to track Cardiac Output as measured with TTE.
Measured: 15 minutes after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start6 Mar 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus RhythmStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ROUGET, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637126
- Sponsor's protocol ID
- RC31/19/0494
- Other IDs
- 2019-A03239-48
- Acronym
- TPTD-TTE-SR
- Status last verified
- May 2021
- First submitted
- 6 Nov 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Measurement in Critically Ill Patient in Sinus Rhythm: a Comparison Between Transpulmonary Thermodilution and Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT04637126
- Acronym / sponsor ID
- TPTD-TTE-SR / RC31/19/0494
- Conditions
- Sinus Rhythm
- Keywords
- Cardiac output monitoring, Transthoracic echocardiography, Transpulmonary thermodilution, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- 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.
Cardiac output monitoring is a key component for the diagnosis and management of critically ill patients. The two less invasive methods commonly used in intensive care are transthoracic echocardiography and transpulmonary thermodilution. The objective of this study is to compare accuracy and trending ability of CO measurement by TPTD and TTE in critically ill patients with sinus rhythm.
Detailed description
TTE is an easy noninvasive device now recommended as the first evaluation of the patient in circulatory failure but it present some limits due to poor echogenicity of patients, operator-dependent variability and cannot provide continuous hemodynamic data. TPTD is an invasive technique for CO monitoring recommended especially in shock not responsive to initial therapy.
Few studies have evaluated the level of agreement of each method (TTE and TPTD) with the reference method (pulmonary artery catheter) but they have never been compared between them with strong statistical analysis in particular trending ability.
It could be interesting to determine the level of concordance of these two methods of CO monitoring and trend ability by TPTD relative to TTE.
The investigators hypothesize that CO-TPTD are concordant with those performed by TTE.
Mechanically ventilated patients requiring hemodynamic assessment will be included. CO-TPTD will be measured via intermittent thermodilution. Blindly, a second investigator will use standard-view TTE to estimate CO-TTE as the product of stroke volume and the heart rate obtained during the measurement the blood flow velocity (using a Doppler technique) at the left ventricular outflow tract. A second measurement will be done with the two devices after a fluid challenge when patient requires it to compare trending ability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated and sedated patients with sinus rhythm | – | Other: Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiographyall mechanically ventilated and sedated patients with sinus rhythm hospitalized in our ICU and fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients requiring hemodynamic assessment
Key inclusion criteria (4 listed)
- mechanically ventilated and sedated patients
- with sinus rhythm
- hospitalized in Intensive Care Unit
- fitted with an hemodynamic monitoring by thermodilution technique due to hemodynamic failure
Key exclusion criteria (7 listed)
- age under 18
- arrhythmia
- severe aortic regurgitation or stenosis
- intracardiac shunt
- poor echogenicity
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 |
|---|---|---|
| Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiographyCardiac output is measured for all patients with transpulmonary thermodilution TPTD and transthoracic echocardiography TTE according to the recommendations | Other | mechanically ventilated and sedated patients with sinus rhythm |
Primary outcome
bias between cardiac output measurement by TPTD and by TTE
Time frame: Day 0
bias between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
3 secondary outcomes
percentage error between cardiac output measurement by transthoracic echocardiography and transpulmonary thermodilution
Time frame: Day 0
percentage error between the value of Cardiac Output measured with TTE (transthoracic echocardiography) and the value of Cardiac Output measured withTPTD (transpulmonary thermodilution) after a fluid challenge.
Time frame: 15 minutes after inclusion
The ability of TPTD (transpulmonary thermodilution) to track Cardiac Output as measured with TTE (transthoracic echocardiography)
Time frame: 15 minutes after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Antoine ROUGET, PH principal investigator
University Hospital, Toulouse
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 Sinus Rhythm, run by University Hospital, Toulouse at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jun 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bias between cardiac output measurement by TPTD and by TTE (time frame: Day 0). 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 1 Jun 2021.