Cardiac SurgeryNCT04711798
Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery
An observational study of Cardiac Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- passive leg raising maneuver (PLR), lung recruitment maneuver (LRM) and echographic evaluation of the right cardiac function
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 29 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receive cardiac surgery will be included.
Who may be able to join
- Patients receiving an elective or urgent cardiac surgery with or without extracorporeal circulation under general anesthesia, under protective mechanical ventilation, monitored by invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement and central venous pressure
Who cannot join
- Left ventricular ejection fraction ≤ 30%
- heart arrhythmia, pulmonary hypertension (SPAP > 35 mmHg)
- right heart failure (TAPSE < 16 mm, S' at lateral tricuspid valve < 10 cm/sec)
- lower limbs obstructive arteriopathy (stage IIb, III and IV)
- severe and very severe chronic obstructive pulmonary disease (COPD)
- pneumothorax and extreme weights (BMI < 35 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.
- Conditions
- Cardiac Surgery
- Being tested
- passive leg raising maneuver (PLR), lung recruitment maneuver (LRM), echographic evaluation of the right cardiac function
- Keywords
- Lung recruitment maneuver, Fluid responsiveness, cardiac surgery, right cardiac dysfunction, passive leg raising, Transcardiopulmonary Thermodilution, Calibrated Arterial Waveform Analysis, echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raising maneuver (PLR)Other
Passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
lung recruitment maneuver (LRM)Other
lung recruitment maneuver (LRM) will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
echographic evaluation of the right cardiac functionOther
echographic evaluation of the right cardiac function will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving cardiac surgery | Patients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function. Receives: Other: passive leg raising maneuver (PLR); Other: lung recruitment maneuver (LRM); Other: echographic evaluation of the right cardiac function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.
Measured by PICCO results (phase: 1, 2, 3).
Measured: Months: 4
Secondary outcomes (2)
Analysis Right cardiac function - Transthoracic echocardiography
measured with Transthoracic echocardiography (phase 1, 3).
Measured: Months: 4
Analysis Right cardiac function - transoesophageal echocardiography
measured with transoesophageal echocardiography (phase 1, 2).
Measured: Months: 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start3 Feb 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille BELLOT, resident, Study chair, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711798
- Sponsor's protocol ID
- IRBN172020/CHUSTE
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2021
- Last updated
- 4 Feb 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04711798
- Acronym / sponsor ID
- IRBN172020/CHUSTE
- Conditions
- Cardiac Surgery
- Keywords
- Lung recruitment maneuver, Fluid responsiveness, cardiac surgery, right cardiac dysfunction, passive leg raising, Transcardiopulmonary Thermodilution, Calibrated Arterial Waveform Analysis, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 15 Jan 2021 (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.
The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving cardiac surgery | – | Other: passive leg raising maneuver (PLR), Other: lung recruitment maneuver (LRM), Other: echographic evaluation of the right cardiac functionPatients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive cardiac surgery will be included.
Key inclusion criteria (1 listed)
- Patients receiving an elective or urgent cardiac surgery with or without extracorporeal circulation under general anesthesia, under protective mechanical ventilation, monitored by invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement and central venous pressure
Key exclusion criteria (6 listed)
- Left ventricular ejection fraction ≤ 30%
- heart arrhythmia, pulmonary hypertension (SPAP > 35 mmHg)
- right heart failure (TAPSE < 16 mm, S' at lateral tricuspid valve < 10 cm/sec)
- lower limbs obstructive arteriopathy (stage IIb, III and IV)
- severe and very severe chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| passive leg raising maneuver (PLR)Passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit). | Other | Patients receiving cardiac surgery |
| lung recruitment maneuver (LRM)lung recruitment maneuver (LRM) will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit). | Other | Patients receiving cardiac surgery |
| echographic evaluation of the right cardiac functionechographic evaluation of the right cardiac function will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit). | Other | Patients receiving cardiac surgery |
Primary outcome
Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.
Time frame: Months: 4
Measured by PICCO results (phase: 1, 2, 3).
2 secondary outcomes
Analysis Right cardiac function - Transthoracic echocardiography
Time frame: Months: 4
Analysis Right cardiac function - transoesophageal echocardiography
Time frame: Months: 4
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 4 Feb 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.
Camille BELLOT, resident study chair
CHU de Saint-Etienne
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 Cardiac Surgery, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 6 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 4 Feb 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?
Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver. (time frame: Months: 4). 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 4 Feb 2021.