Acute Respiratory Distress SyndromeNCT03896802
Hemodynamic Effects of PEEP in ARDS
A study testing Physiological assesment in people with Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Milan at 1 site in Italy.
Trial summary
The purpose of this study is to assess the effect of different levels of PEEP on the cardiocirculatory system in patients affected by the acute respiratory distress syndrome (ARDS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Mechanical Ventilation, ARDS, Human
- What is being tested?
- Physiological assesment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- All patients aged 18 or older and with a recent (<48h) diagnosis of ARDS, undergoing invasive mechanical ventilation and in whom, due to the hemodynamic instability, cardiac output monitoring with an Arterial pulse contour analysis and transpulmonary thermodilution system (PiCCO technology, Pulsion Medical Systems, Germany) will be considered necessary, will be considered for enrolment.
Who cannot join
- Patients with barotrauma and with clinical evidence of intrinsic PEEP will be excluded.
Trial locations and contacts
1 site in 1 country.
Davide Chiumello contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
Milan, MI, 20142
Davide Chiumello, +390281844020, chiumello@libero.it
About this study
Official title: Hemodynamic Effects of PEEP in Patients With ARDS
The purpose of this study is to assess the effect of different levels of PEEP on the cardiocirculatory system in patients affected by the acute respiratory distress syndrome (ARDS)
Read the detailed description
Introduction
Acute respiratory distress syndrome (ARDS) is a clinical syndrome defined by the association of an acute onset of hypoxaemia and bilateral pulmonary infiltrates following a trigger insult; it is characterized by inflammation of the pulmonary tissue, with subsequent development of non-cardiogenic edema. The extent of edema may be such that the weight of the lung may increase up to 2-3 times its original weight. As a consequence, the lung tends to collapse on itself, more so in the dependent areas, i.e. the posterior/dorsal areas when the patient in lying supine, with the consequent development of zones of atelectasis.
These areas, when perfused, are the main cause for the development of the severe form of hypoxemia commonly seen in this condition. Hypoxemia, if severe enough, may bring by itself to the death of the patient. It has to be noted that, despite the advances in the management of critically ill patients, mortality attributable to ARDS currently is about 50%, with a range between 30-70%.
The use of positive end-expiratory pressure (PEEP) has been reported ever since the first description of the syndrome, as a tool to manage and correct hypoxemia. PEEP has thus been used for 40 years, and is an essential part of the management of the syndrome. While the effectiveness of PEEP in improving the oxygenation of the wide part of critically ill patients with ARDS it is out of doubt, its efficacy with respect to outcomes such as mortality has not, so far, been demonstrated. The question is then still open with regards to the setting of an optimal level of PEEP in ARDS.
Frequently, ARDS is associated with the development of hemodynamic instability and shock, to the extent that up to 2/3 of patients suffering from the syndrome require the infusion of catecholamines or show signs of hypoperfusion; circulatory failure seems to be the factor more strongly associated to mortality in these patients, and the strength of the association is higher compared to that of the degree of hypoxemia. In ARDS shock is secondary to three main factors: 1) acute cor pulmonale due to pulmonary hypertension secondary to microvascular occlusion by thrombi or arteriolar remodeling and/or hypoxic pulmonary vasoconstriction; 2) the deleterious hemodynamic effects of mechanical ventilation, especially on right cardiac function; and 3) the possible development of septic myocardial depression.
Acute kidney injury (AKI) is common in critically ill patients and it is associated with poor outcomes. An increasing body of evidence points to the existence of deleterious interactions between kidney and lung dysfunctions in a vicious cross-talk. Several studies seem to suggest that mechanical ventilation and ARDS may have adverse effects on kidney function via three main mechanisms: 1) positive-pressure ventilation may lead to a reduction in cardiac output and an increase central venous pressure, thereby diminishing renal blood flow, free water clearance, and the glomerular filtration rate; 2) changes in arterial blood oxygen (O2) or carbon dioxide (CO2) may influence renal vascular resistance, renal perfusion, or diuresis; and, finally, 3) emerging data suggest that ventilator-induced lung injury may not only affect the lung, but may also lead to further systemic inflammation via the systemic release of inflammatory cytokines.
Indeed, the hemodynamic effect of PEEP depends on how much of the positive pressure applied to the alveoli is transmitted to the mediastinal structures (heart and big vessels), and the effect on renal function depends on how much this interferes with renal hemodynamic. The transmission of airway pressure, in turn, depends on the mechanical characteristics of the lung and the chest wall, which are known to be variably and unpredictably affected in ARDS.
The main question of this research project deals with the hemodynamic impact of PEEP in patients with ARDS, in terms of effects on the cardiocirculatory system.
Rationale
Hemodynamic effects of mechanical ventilation The hemodynamic effects of mechanical ventilation are mainly secondary to cyclic oscillations in pleural pressure (Ppl) and transpulmonary pressure (Ptp). Variations in pleural pressure mainly interfere with inflow of blood into the right ventricle, and with ejection of blood from the left ventricle. On the other side, variations in transpulmonary pressure mainly affect the inflow of blood into the left ventricle and ejection of blood from the right ventricle. While the large vessels of systemic circulation are surrounded by the constant atmospheric pressure, central vessels of the pulmonary circulation are surrounded by pleural pressure, which in turn may significantly vary compared to atmospheric pressure during the whole respiratory cycle. Positive-pressure mechanical ventilation exerts an effect which is opposed to the physiologic inspiratory negativisation of pleural pressure. Indeed, the increase in pleural pressure secondary to positive airway pressure reduces left ventricular afterload, while at the same time it reduces right ventricular preload. Since the normal pressure gradient which drives blood from periphery to the right heart lies in the range of 4-8 mmHg, even small increases in pleural pressure may have a significant impact on venous return. Moreover, the presence of PEEP has a hemodynamic effect during the whole respiratory cycle. As a rule of thumb, it is generally estimated that up to about 50% of the variation in airway pressure is transmitted as a variation in pleural pressure in patients with normally functioning lungs. This effect is however likely reduced in case of an increased lung elastance (i.e. the presence of stiff lungs, as in patients with ARDS), given that a reduced amount of airway pressure is transmitted at the pleural level. However, this depends on the ratio between lung elastance and respiratory system elastance, which may vary widely in ARDS. Moreover, as the right ventricle generally displays a high level of compliance despite a limited myocardial thickness and a reduced contractile force, this may be more affected from increments in afterload rather than by variations in preload.
On the other side, the increase in mean airway pressure as a consequence of the application of PEEP leads to an increase in the size of the lung (increase in end-expiratory lung volume), mainly through the recruitment of previously closed and derecruited zones. However, the application of PEEP may also lead to overdistention of already open and ventilated pulmonary units, leading to a certain degree of vascular occlusion of the critical closing pressure of those vessels is reached and overcome (as in the case of West zones I and II, in which alveolar pressure in higher than arterial and venous pulmonary pressure, respectively).
The hemodynamic effect of PEEP might then be different, as a function of the amount of pulmonary units that can be recruited. In conclusion, the knowledge of the effect on the cardiocirculatory system of the application of a high or low level of PEEP may require the measure or at least an estimate of the potential for lung recruitment.
Measurement and estimate of the potential for lung recruitment The gold standard for the measurement of the potential for lung recruitment is represented by pulmonary CT scan. This technique has been used together with quantitative analysis of regional and global lung aeration by our group since 1987 for the analysis of parenchymal response to PEEP in patients with ARDS. An estimate of the potential for lung recruitment may be inferred at the bedside by the assessment of the effect of PEEP on the level of oxygenation, physiologic dead-space and partitioned lung compliance, to be able to differentiate recruitment from overdistention.
Main hypothesis The main hypothesis behind the present research project is that critically ill patients with ARDS and an elevated potential for lung recruitment will be less affected by the hemodynamic effects of PEEP than patients with a lower potential for lung recruitment. If this hypothesis was to be confirmed, the application of PEEP would be less troublesome, at least for the concerns for the hemodynamic compromise, in patients with ARDS and a higher potential for lung recruitment. This issue has so far never been investigated, and the present research might significantly extend our knowledge on the topic.
- Being tested
- Physiological assesment
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological assesmentProcedure or surgery
- Arterial and mixed venous blood gas analysis.
- Alveolar and physiologic dead space via volumetric capnometry, as well as carbon dioxide (CO2) production, end-tidal CO2 and mixed expired CO2
- Respiratory system (Crs), chest wall (Ccw) and lung (Cl) compliance measurement via an end-inspiratory and end-expiratory pause.
- Arterial blood pressure, central venous pressure (CVP), heart rate, cardiac output through the arterial pulse contour and transpulmonary thermodilution methods (PiCCO technology). Global end-diastolic volume, Intra-thoracic blood volume, Extravascular lung water will also be assessed. Respiratory hold maneuvers (at PEEP, and +10, +15 and +20 cmH2O) will be performed and CVP and cardiac output will be measured in the last 3 s of the 12 s inspiratory hold. Venous return curve will constructed and the zero-flow pressure recorded as the mean systemic filling pressure.
- Urine flow in 1h and determination of the fractional excretion of sodium and creatinine.
| Study group | Role | What they receive |
|---|---|---|
| Low PEEP | Experimental | PEEP 5 cmH2O Receives: Procedure: Physiological assesment |
| High PEEP | Experimental | PEEP 15 cmH2O Receives: Procedure: Physiological assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Cardiac output (in l/min) will be measured by transpulmonary thermodilution and arterial pulse contour analysis
Measured: Study 1 day
Secondary outcomes (2)
Transmural central venous pressure
Measured and CVP minus esophageal pressure
Measured: Study 1 day
Mean systemic filling pressure
Measured with the respiratory hold method
Measured: Study 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896802
- Sponsor's protocol ID
- ARDS-HEMO
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 2 Apr 2019
- 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 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of PEEP in Patients With ARDS
- ClinicalTrials.gov ID
- NCT03896802
- Acronym / sponsor ID
- ARDS-HEMO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Apr 2019 (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 purpose of this study is to assess the effect of different levels of PEEP on the cardiocirculatory system in patients affected by the acute respiratory distress syndrome (ARDS)
Detailed description
Introduction
Acute respiratory distress syndrome (ARDS) is a clinical syndrome defined by the association of an acute onset of hypoxaemia and bilateral pulmonary infiltrates following a trigger insult; it is characterized by inflammation of the pulmonary tissue, with subsequent development of non-cardiogenic edema. The extent of edema may be such that the weight of the lung may increase up to 2-3 times its original weight. As a consequence, the lung tends to collapse on itself, more so in the dependent areas, i.e. the posterior/dorsal areas when the patient in lying supine, with the consequent development of zones of atelectasis.
These areas, when perfused, are the main cause for the development of the severe form of hypoxemia commonly seen in this condition. Hypoxemia, if severe enough, may bring by itself to the death of the patient. It has to be noted that, despite the advances in the management of critically ill patients, mortality attributable to ARDS currently is about 50%, with a range between 30-70%.
The use of positive end-expiratory pressure (PEEP) has been reported ever since the first description of the syndrome, as a tool to manage and correct hypoxemia. PEEP has thus been used for 40 years, and is an essential part of the management of the syndrome. While the effectiveness of PEEP in improving the oxygenation of the wide part of critically ill patients with ARDS it is out of doubt, its efficacy with respect to outcomes such as mortality has not, so far, been demonstrated. The question is then still open with regards to the setting of an optimal level of PEEP in ARDS.
Frequently, ARDS is associated with the development of hemodynamic instability and shock, to the extent that up to 2/3 of patients suffering from the syndrome require the infusion of catecholamines or show signs of hypoperfusion; circulatory failure seems to be the factor more strongly associated to mortality in these patients, and the strength of the association is higher compared to that of the degree of hypoxemia. In ARDS shock is secondary to three main factors: 1) acute cor pulmonale due to pulmonary hypertension secondary to microvascular occlusion by thrombi or arteriolar remodeling and/or hypoxic pulmonary vasoconstriction; 2) the deleterious hemodynamic effects of mechanical ventilation, especially on right cardiac function; and 3) the possible development of septic myocardial depression.
Acute kidney injury (AKI) is common in critically ill patients and it is associated with poor outcomes. An increasing body of evidence points to the existence of deleterious interactions between kidney and lung dysfunctions in a vicious cross-talk. Several studies seem to suggest that mechanical ventilation and ARDS may have adverse effects on kidney function via three main mechanisms: 1) positive-pressure ventilation may lead to a reduction in cardiac output and an increase central venous pressure, thereby diminishing renal blood flow, free water clearance, and the glomerular filtration rate; 2) changes in arterial blood oxygen (O2) or carbon dioxide (CO2) may influence renal vascular resistance, renal perfusion, or diuresis; and, finally, 3) emerging data suggest that ventilator-induced lung injury may not only affect the lung, but may also lead to further systemic inflammation via the systemic release of inflammatory cytokines.
Indeed, the hemodynamic effect of PEEP depends on how much of the positive pressure applied to the alveoli is transmitted to the mediastinal structures (heart and big vessels), and the effect on renal function depends on how much this interferes with renal hemodynamic. The transmission of airway pressure, in turn, depends on the mechanical characteristics of the lung and the chest wall, which are known to be variably and unpredictably affected in ARDS.
The main question of this research project deals with the hemodynamic impact of PEEP in patients with ARDS, in terms of effects on the cardiocirculatory system.
Rationale
Hemodynamic effects of mechanical ventilation The hemodynamic effects of mechanical ventilation are mainly secondary to cyclic oscillations in pleural pressure (Ppl) and transpulmonary pressure (Ptp). Variations in pleural pressure mainly interfere with inflow of blood into the right ventricle, and with ejection of blood from the left ventricle. On the other side, variations in transpulmonary pressure mainly affect the inflow of blood into the left ventricle and ejection of blood from the right ventricle. While the large vessels of systemic circulation are surrounded by the constant atmospheric pressure, central vessels of the pulmonary circulation are surrounded by pleural pressure, which in turn may significantly vary compared to atmospheric pressure during the whole respiratory cycle. Positive-pressure mechanical ventilation exerts an effect which is opposed to the physiologic inspiratory negativisation of pleural pressure. Indeed, the increase in pleural pressure secondary to positive airway pressure reduces left ventricular afterload, while at the same time it reduces right ventricular preload. Since the normal pressure gradient which drives blood from periphery to the right heart lies in the range of 4-8 mmHg, even small increases in pleural pressure may have a significant impact on venous return. Moreover, the presence of PEEP has a hemodynamic effect during the whole respiratory cycle. As a rule of thumb, it is generally estimated that up to about 50% of the variation in airway pressure is transmitted as a variation in pleural pressure in patients with normally functioning lungs. This effect is however likely reduced in case of an increased lung elastance (i.e. the presence of stiff lungs, as in patients with ARDS), given that a reduced amount of airway pressure is transmitted at the pleural level. However, this depends on the ratio between lung elastance and respiratory system elastance, which may vary widely in ARDS. Moreover, as the right ventricle generally displays a high level of compliance despite a limited myocardial thickness and a reduced contractile force, this may be more affected from increments in afterload rather than by variations in preload.
On the other side, the increase in mean airway pressure as a consequence of the application of PEEP leads to an increase in the size of the lung (increase in end-expiratory lung volume), mainly through the recruitment of previously closed and derecruited zones. However, the application of PEEP may also lead to overdistention of already open and ventilated pulmonary units, leading to a certain degree of vascular occlusion of the critical closing pressure of those vessels is reached and overcome (as in the case of West zones I and II, in which alveolar pressure in higher than arterial and venous pulmonary pressure, respectively).
The hemodynamic effect of PEEP might then be different, as a function of the amount of pulmonary units that can be recruited. In conclusion, the knowledge of the effect on the cardiocirculatory system of the application of a high or low level of PEEP may require the measure or at least an estimate of the potential for lung recruitment.
Measurement and estimate of the potential for lung recruitment The gold standard for the measurement of the potential for lung recruitment is represented by pulmonary CT scan. This technique has been used together with quantitative analysis of regional and global lung aeration by our group since 1987 for the analysis of parenchymal response to PEEP in patients with ARDS. An estimate of the potential for lung recruitment may be inferred at the bedside by the assessment of the effect of PEEP on the level of oxygenation, physiologic dead-space and partitioned lung compliance, to be able to differentiate recruitment from overdistention.
Main hypothesis The main hypothesis behind the present research project is that critically ill patients with ARDS and an elevated potential for lung recruitment will be less affected by the hemodynamic effects of PEEP than patients with a lower potential for lung recruitment. If this hypothesis was to be confirmed, the application of PEEP would be less troublesome, at least for the concerns for the hemodynamic compromise, in patients with ARDS and a higher potential for lung recruitment. This issue has so far never been investigated, and the present research might significantly extend our knowledge on the topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low PEEP | Experimental | Procedure: Physiological assesmentPEEP 5 cmH2O |
| High PEEP | Experimental | Procedure: Physiological assesmentPEEP 15 cmH2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 or older and with a recent (<48h) diagnosis of ARDS, undergoing invasive mechanical ventilation and in whom, due to the hemodynamic instability, cardiac output monitoring with an Arterial pulse contour analysis and transpulmonary thermodilution system (PiCCO technology, Pulsion Medical Systems, Germany) will be considered necessary, will be considered for enrolment.
Key exclusion criteria (1 listed)
- Patients with barotrauma and with clinical evidence of intrinsic PEEP will be excluded.
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 |
|---|---|---|
| Physiological assesment1. Arterial and mixed venous blood gas analysis. 2. Alveolar and physiologic dead space via volumetric capnometry, as well as carbon dioxide (CO2) production, end-tidal CO2 and mixed expired CO2 3. Respiratory system (Crs), chest wall (Ccw) and lung (Cl) compliance measurement via an end-inspiratory and end-expiratory pause. 4. Arterial blood pressure, central venous pressure (CVP), heart rate, cardiac output through the arterial pulse contour and transpulmonary thermodilution methods (PiCCO technology). Global end-diastolic volume, Intra-thoracic blood volume, Extravascular lung water will also be assessed. Respiratory hold maneuvers (at PEEP, and +10, +15 and +20 cmH2O) will be performed and CVP and cardiac output will be measured in the last 3 s of the 12 s inspiratory hold. Venous return curve will constructed and the zero-flow pressure recorded as the mean systemic filling pressure. 5. Urine flow in 1h and determination of the fractional excretion of sodium and creatinine. | Procedure or surgery | High PEEP, Low PEEP |
Primary outcome
Cardiac Output
Time frame: Study 1 day
Cardiac output (in l/min) will be measured by transpulmonary thermodilution and arterial pulse contour analysis
2 secondary outcomes
Transmural central venous pressure
Time frame: Study 1 day
Mean systemic filling pressure
Time frame: Study 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- 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.
Davide Chiumello contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological assesment in people with Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Milan at 1 site in Italy.
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 1 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 2 Apr 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 Italy. 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?
Contact Davide Chiumello (+390281844020, chiumello@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: Study 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 2 Apr 2019.