Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525480
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Mechanical RespiratoryCirculatory Support in Patients With Pulmonary Thrombectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pulmonary Thromboembolism in Patients Undergoing Percutaneous Pulmonary Thrombectomy Need for Mechanical Respiratory andor Circulatory Assistance
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary embolism PE results from embolization of venous thrombi in the branches of the pulmonary arteries
Although anticoagulation is usually the preferred method of treatment patients with high-risk andor intermediatehigh-risk pulmonary embolism may benefit from immediate reperfusion therapy such as mechanical catheter thrombectomy During this procedure there may be an increase in pulmonary pressures caused by the introduction of pulmonary catheters which may trigger hemodynamic instability In addition anesthesia performed during percutaneous mechanical thrombectomy may precipitate hemodynamic and respiratory compromise due to hypoxia hypercapnia and increased airway pressure
We will perform a retrospective single-center study to determine the incidence and immediate causes of hemodynamic andor respiratory deterioration before during and after first 30 days of percutaneous pulmonary thrombectomy as well as the need for mechanical respiratorycirculatory support
Although anticoagulation is usually the preferred method of treatment patients with high-risk andor intermediatehigh-risk pulmonary embolism may benefit from immediate reperfusion therapy such as mechanical catheter thrombectomy During this procedure there may be an increase in pulmonary pressures caused by the introduction of pulmonary catheters which may trigger hemodynamic instability In addition anesthesia performed during percutaneous mechanical thrombectomy may precipitate hemodynamic and respiratory compromise due to hypoxia hypercapnia and increased airway pressure
We will perform a retrospective single-center study to determine the incidence and immediate causes of hemodynamic andor respiratory deterioration before during and after first 30 days of percutaneous pulmonary thrombectomy as well as the need for mechanical respiratorycirculatory support
Detailed Description:
Pulmonary embolism PE is a consequence of the embolization of venous thrombi in the branches of the pulmonary arteries It affects approximately 1 in 1000 people per year worldwide and represents the third cause of cardiovascular death
The degree of hemodynamic compromise due to PE can be determined by imaging studies such as computed tomography angiography transthoracic echocardiography TTE and transesophageal echocardiography TEE Additionally laboratory tests may suggest circulatory compromise such as elevated levels of cardiac troponin and N-terminal pro b-type natriuretic peptide NT-proBNP at the time of PE presentation
There are different classifications to evaluate the severity of PE and we consider the presence of hemodynamic instability to differentiate high-risk PE from intermediate-risk PE The presence of hemodynamic instability includes a state of obstructive shock signs of hypoperfusion associated with a systolic blood pressure SBP 90mmHg andor SBP 90mmHg with the need for vasoactive drugs persistent hypotension SBP90mmHg for 15 min or SBP decrease 40mmHg compared to baseline or cardiac arrest with the need for cardiopulmonary resuscitation CPR The high risk of PE also includes the existence of some parameter included in the sPESI such as history of cancer age over 80 years heart rate 110 bpm history of chronic obstructive pulmonary disease SBP 100 mmHg and SpO2 90
Patients with high-risk andor intermediatehigh-risk pulmonary embolism benefit from immediate reperfusion therapy such as systemic thrombolysis catheter-directed thrombolysis catheter thrombectomy or surgery Although the incidence of complications and mortality in high-risk PE patients has been determined the incidence and immediate causes of hemodynamic andor respiratory deterioration before during and after pulmonary thrombectomy are unknown Pulmonary thrombectomy is a technique that consists of the extraction or dissolution using endovascular devices of the thrombus that partially or totally obstructs a pulmonary artery It is generally associated with the local intra-thrombus administration of thrombolytic drugs The increase in pulmonary intravascular pressure generated during the procedure can trigger the appearance of complications arrhythmias acute overload of the right ventricle hemodynamic andor respiratory instability shock cardiovascular arrest These complications usually require an increase in hemodynamic support with an increase in vasoactive drugs andor respiratory support orotracheal intubation and mechanical ventilation and even mechanical support with ECMO usually veno-arterial ECMO for cardiovascular assistance Also the type of anesthesia performed can precipitate the hemodynamic andor respiratory compromise of patients due to the possible presence of hypoxia and hypercapnia in patients who present hypoventilation and the increase in airway pressures caused by orotracheal intubation and mechanical ventilation In some cases the use of mechanical circulatory support usually ECMO may be justified but it is currently unclear whether VA-ECMO should be initiated in all high-risk PE patients It must be considered that VA-ECMO is associated with innumerable complications bleeding thrombi vascular complications which increase the longer the duration of support
Determining the incidence and causes or context of the onset of hemodynamic andor respiratory deterioration leading to shock need for orotracheal intubation cardiopulmonary arrest andor mechanical support with ECMO before during and after thrombectomy pulmonary disease could help reduce the morbidity and mortality of these patients
The degree of hemodynamic compromise due to PE can be determined by imaging studies such as computed tomography angiography transthoracic echocardiography TTE and transesophageal echocardiography TEE Additionally laboratory tests may suggest circulatory compromise such as elevated levels of cardiac troponin and N-terminal pro b-type natriuretic peptide NT-proBNP at the time of PE presentation
There are different classifications to evaluate the severity of PE and we consider the presence of hemodynamic instability to differentiate high-risk PE from intermediate-risk PE The presence of hemodynamic instability includes a state of obstructive shock signs of hypoperfusion associated with a systolic blood pressure SBP 90mmHg andor SBP 90mmHg with the need for vasoactive drugs persistent hypotension SBP90mmHg for 15 min or SBP decrease 40mmHg compared to baseline or cardiac arrest with the need for cardiopulmonary resuscitation CPR The high risk of PE also includes the existence of some parameter included in the sPESI such as history of cancer age over 80 years heart rate 110 bpm history of chronic obstructive pulmonary disease SBP 100 mmHg and SpO2 90
Patients with high-risk andor intermediatehigh-risk pulmonary embolism benefit from immediate reperfusion therapy such as systemic thrombolysis catheter-directed thrombolysis catheter thrombectomy or surgery Although the incidence of complications and mortality in high-risk PE patients has been determined the incidence and immediate causes of hemodynamic andor respiratory deterioration before during and after pulmonary thrombectomy are unknown Pulmonary thrombectomy is a technique that consists of the extraction or dissolution using endovascular devices of the thrombus that partially or totally obstructs a pulmonary artery It is generally associated with the local intra-thrombus administration of thrombolytic drugs The increase in pulmonary intravascular pressure generated during the procedure can trigger the appearance of complications arrhythmias acute overload of the right ventricle hemodynamic andor respiratory instability shock cardiovascular arrest These complications usually require an increase in hemodynamic support with an increase in vasoactive drugs andor respiratory support orotracheal intubation and mechanical ventilation and even mechanical support with ECMO usually veno-arterial ECMO for cardiovascular assistance Also the type of anesthesia performed can precipitate the hemodynamic andor respiratory compromise of patients due to the possible presence of hypoxia and hypercapnia in patients who present hypoventilation and the increase in airway pressures caused by orotracheal intubation and mechanical ventilation In some cases the use of mechanical circulatory support usually ECMO may be justified but it is currently unclear whether VA-ECMO should be initiated in all high-risk PE patients It must be considered that VA-ECMO is associated with innumerable complications bleeding thrombi vascular complications which increase the longer the duration of support
Determining the incidence and causes or context of the onset of hemodynamic andor respiratory deterioration leading to shock need for orotracheal intubation cardiopulmonary arrest andor mechanical support with ECMO before during and after thrombectomy pulmonary disease could help reduce the morbidity and mortality of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None