Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05922631
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2023-06-19
Brief Title:
Effect of APRV vs LTV on Right Heart Function in ARDS Patients a Single-center Randomized Controlled Study
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Effect of Airway Pressure Release Ventilation vs Low Tidal Volume Ventilation on Right Heart Function in Acute Respiratory Distress Syndrome Patients a Single-center Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute Respiratory Distress Syndrome ARDS is often complicated by Right Ventricular Dysfunction RVD and the incidence can be as high as 64 The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction Pulmonary vascular dysfunction includes acute vascular inflammation pulmonary vascular edema thrombosis and pulmonary vascular remodeling Alveolar collapse and over distension can also lead to increased pulmonary vascular resistance Preventing the development of acute cor pulmonale in patients with acute respiratory distress ARDS patients with RVD have a worse prognosis and a significantly increased risk of death which is an independent risk factor for death in ARDS patients Therefore implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD
APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure which can effectively improve oxygenation and reduce ventilator-associated lung injury However its effect on right ventricular function is still controversial Low tidal volume LTV is a mechanical ventilation strategy widely used in ARDS patients Meta-analysis results showed that compared with LTV APRV improved oxygenation more significantly reduced the time of mechanical ventilation and even had a tendency to improve the mortality of ARDS patients However randomized controlled studies have shown that compared with LTV APRV improves oxygenation more significantly and also increases the mean airway pressure Therefore some scholars speculate that APRV may increase the intrathoracic pressure pulmonary circulatory resistance and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence In addition APRV may improve right ventricular function by correcting hypoxia and hypercapnia promoting lung recruitment and reducing pulmonary circulation resistance Therefore it is very important to clarify this effect for whether APRV can be safely used and popularized in clinicwe aim to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS pulmonary circulatory resistance PVR right ventricular-pulmonary artery coupling RV-PA coupling and pulmonary vascular resistance PVR
APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure which can effectively improve oxygenation and reduce ventilator-associated lung injury However its effect on right ventricular function is still controversial Low tidal volume LTV is a mechanical ventilation strategy widely used in ARDS patients Meta-analysis results showed that compared with LTV APRV improved oxygenation more significantly reduced the time of mechanical ventilation and even had a tendency to improve the mortality of ARDS patients However randomized controlled studies have shown that compared with LTV APRV improves oxygenation more significantly and also increases the mean airway pressure Therefore some scholars speculate that APRV may increase the intrathoracic pressure pulmonary circulatory resistance and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence In addition APRV may improve right ventricular function by correcting hypoxia and hypercapnia promoting lung recruitment and reducing pulmonary circulation resistance Therefore it is very important to clarify this effect for whether APRV can be safely used and popularized in clinicwe aim to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS pulmonary circulatory resistance PVR right ventricular-pulmonary artery coupling RV-PA coupling and pulmonary vascular resistance PVR
Detailed Description:
Acute Respiratory DistressSyndrome ARDS is often complicated by Right Ventricular Dysfunction RVD and the incidence can be as high as 64 The mechanism includes pulmonary vascular dysfunction and right heart systolic dysfunction Pulmonary vascular dysfunction includes acute vascular inflammation pulmonary vascular edema thrombosis and pulmonary vascular remodeling Alveolar collapse and alveolar overdistension can also lead to increased pulmonary vascular resistance Preventing the development of acute cor pulmonale in patients with acute respiratory distress ARDS patients with RVD have a worse prognosis and a significantly increased risk of death which is an independent risk factor for death in ARDS patients 2-4 Therefore implementing a right heart-protective mechanical ventilation strategy may reduce the incidence of RVD
Mechanical ventilation is the main treatment for moderate to severe ARDS Mechanical ventilation promotes lung recruitment and reduces mechanical compression of pulmonary vessels between alveoli and alveolar walls In addition mechanical ventilation corrected hypoxemia and hypercapnia thereby reducing reactive pulmonary vasoconstriction All of the above can reduce pulmonary circulation resistance and right ventricular afterload thereby improving right ventricular function in patients with ARDS However if hyperventilation occurs it will increase the mechanical compression of pulmonary vessels on the alveolar wall increase the intrathoracic pressure and increase the afterload of the right heart which will adversely affect the function of the right heart There are a variety of ventilation strategies for patients with ARDS in clinical practice but which mechanical ventilation has the protective function of right heart or has little effect on right heart function so far there is a lack of relevant research reports
Airway pressure release ventilation APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure which can effectively improve oxygenation and reduce ventilator-associated lung injury However its effect on right ventricular function is still controversial so its clinical application is not popular and it is only used as one of the salvage treatments for ARDS patients Low tidal volume LTV is a mechanical ventilation strategy widely used in ARDS patients but it does not further reduce mortality in patients with moderate to severe ARDS Meta-analysis results showed that compared with LTV APRV improved oxygenation more significantly reduced the time of mechanical ventilation and even had a tendency to improve the mortality of ARDS patients 7 However randomized controlled studies have shown that compared with LTV APRV improves oxygenation more significantly and also increases the mean airway pressure 8 Therefore some scholars speculate that APRV may increase the intrathoracic pressure pulmonary circulatory resistance and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence In addition the results of animal experiments suggest that APRV improves oxygenation promotes lung recruitment and improves the heterogeneity of lung lesions in ARDS without causing lung hyperventilation suggesting that APRV may not increase pulmonary circulatory resistance In addition APRV may improve right ventricular function by correcting hypoxia and hypercapnia promoting lung recruitment and reducing pulmonary circulation resistance Therefore the impact of APRV on right ventricular function is still unclear and it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic Therefore our research group conducted a prospective observational study The effect of APRV on right ventricular function evaluated by Transthoracic Echocardiography 2022 Lun Lun Zi 0075 The study results suggested that APRV improved lung perfusion in ARDS patients while effectively improving oxygenation and promoting lung recruitment The incidence of RVD was not increased and there was no hemodynamic deterioration in ARDS patients APRV is safe and effective for patients with ARDS However the results of a single-arm prospective observational study with a small sample size cannot provide strong evidence for clinical practice In the previous studies all the right ventricular function was assessed by transthoracic echocardiography Due to the limitation of the sound window of transthoracic echocardiography the right ventricular function of some ARDS patients could not be evaluated Therefore this study intends to use transesophageal echocardiography or transthoracic echocardiography to fully evaluate the right ventricular function of all enrolled patients as much as possible and to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS pulmonary circulatory resistance PVR right ventricular-pulmonary artery coupling RV-PA coupling and pulmonary vascular resistance PVRWhether there are different effects on hemodynamics and mortality It is hoped that the results of this study will provide more evidence support for the clinical application of APRV and benefit more ARDS patients
Mechanical ventilation is the main treatment for moderate to severe ARDS Mechanical ventilation promotes lung recruitment and reduces mechanical compression of pulmonary vessels between alveoli and alveolar walls In addition mechanical ventilation corrected hypoxemia and hypercapnia thereby reducing reactive pulmonary vasoconstriction All of the above can reduce pulmonary circulation resistance and right ventricular afterload thereby improving right ventricular function in patients with ARDS However if hyperventilation occurs it will increase the mechanical compression of pulmonary vessels on the alveolar wall increase the intrathoracic pressure and increase the afterload of the right heart which will adversely affect the function of the right heart There are a variety of ventilation strategies for patients with ARDS in clinical practice but which mechanical ventilation has the protective function of right heart or has little effect on right heart function so far there is a lack of relevant research reports
Airway pressure release ventilation APRV is an inverse mechanical ventilation mode with transient pressure release under continuous positive airway pressure which can effectively improve oxygenation and reduce ventilator-associated lung injury However its effect on right ventricular function is still controversial so its clinical application is not popular and it is only used as one of the salvage treatments for ARDS patients Low tidal volume LTV is a mechanical ventilation strategy widely used in ARDS patients but it does not further reduce mortality in patients with moderate to severe ARDS Meta-analysis results showed that compared with LTV APRV improved oxygenation more significantly reduced the time of mechanical ventilation and even had a tendency to improve the mortality of ARDS patients 7 However randomized controlled studies have shown that compared with LTV APRV improves oxygenation more significantly and also increases the mean airway pressure 8 Therefore some scholars speculate that APRV may increase the intrathoracic pressure pulmonary circulatory resistance and the risk of right heart dysfunction but this speculation is not supported by clinical research evidence In addition the results of animal experiments suggest that APRV improves oxygenation promotes lung recruitment and improves the heterogeneity of lung lesions in ARDS without causing lung hyperventilation suggesting that APRV may not increase pulmonary circulatory resistance In addition APRV may improve right ventricular function by correcting hypoxia and hypercapnia promoting lung recruitment and reducing pulmonary circulation resistance Therefore the impact of APRV on right ventricular function is still unclear and it is very important to clarify this effect for whether APRV can be safely used and popularized in clinic Therefore our research group conducted a prospective observational study The effect of APRV on right ventricular function evaluated by Transthoracic Echocardiography 2022 Lun Lun Zi 0075 The study results suggested that APRV improved lung perfusion in ARDS patients while effectively improving oxygenation and promoting lung recruitment The incidence of RVD was not increased and there was no hemodynamic deterioration in ARDS patients APRV is safe and effective for patients with ARDS However the results of a single-arm prospective observational study with a small sample size cannot provide strong evidence for clinical practice In the previous studies all the right ventricular function was assessed by transthoracic echocardiography Due to the limitation of the sound window of transthoracic echocardiography the right ventricular function of some ARDS patients could not be evaluated Therefore this study intends to use transesophageal echocardiography or transthoracic echocardiography to fully evaluate the right ventricular function of all enrolled patients as much as possible and to conduct a single-center randomized controlled study to further compare the effects of APRV and LTV on right ventricular function in patients with ARDS pulmonary circulatory resistance PVR right ventricular-pulmonary artery coupling RV-PA coupling and pulmonary vascular resistance PVRWhether there are different effects on hemodynamics and mortality It is hoped that the results of this study will provide more evidence support for the clinical application of APRV and benefit more ARDS patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None