Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465114
Status:
WITHDRAWN
Last Update Posted:
2018-02-06
First Post:
2007-04-23
Brief Title:
Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia Radial Artery Wave Form Analysis Versus Trans-thoracic Echocardiogram
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility issues only 1 patient recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe preeclampsia often presents with uncontrolled hypertension and therefore requires close monitoring of blood pressure and cardiac performance
The purpose of the study is to compare two methods of measuring the performance of the heart in pregnant women one by ultrasound of the heart the other by assessing the pulse generated in the blood vessel of the wrist We hope that the method using pulse analysis will be as effective as ultrasound which is labour intensive and operator dependant
The purpose of the study is to compare two methods of measuring the performance of the heart in pregnant women one by ultrasound of the heart the other by assessing the pulse generated in the blood vessel of the wrist We hope that the method using pulse analysis will be as effective as ultrasound which is labour intensive and operator dependant
Detailed Description:
Severe preeclampsia often presents with uncontrolled hypertension which requires close monitoring of blood pressure and cardiac output It will be very useful to know the cardiac output in this patient population because it will guide the choice of antihypertensive drugs and measure their effect on cardiac output
Traditionally pulmonary artery catheters were used to measure cardiac output There are numerous problems with using this method in severe preeclampsia These include technical difficulty inserting the catheter in an awake edematous pregnant patient potentially causing a pneumothorax damaging the carotid artery or insertion site infection There is also an increased risk for cardiac arrhythmias Apart from the risks the accuracy of the thermodilution measurements can be influenced by factors such as timing of the injection within the respiratory cycle temperature of the injectate speed of injection and placement of the catheter A readily available accurate non-invasive cardiac output measurement technique that will provide reliable data with fewer risks is needed
Doppler ultrasound trans thoracic echocardiography is the gold standard for measuring cardiac output non-invasively in pregnant patients Unfortunately the method is operator dependant not continuous and not always available when needed most
Recently a device called the FloTrac has been introduced that measures cardiac output minimally invasively Attached to an arterial line it measures cardiac output every 20 seconds via arterial waveform analysis The standard of care for measuring blood pressure in severe preeclampsia requires the placement of an intra-arterial line This group of patients is therefore ideal for measuring cardiac output with the FloTrac especially since powerful intravenous anti-hypertensives are used to control blood pressure
Our hypothesis is that the FloTrac will be comparable to Doppler Ultrasound for measuring cardiac output in severely preeclamptic patients
Traditionally pulmonary artery catheters were used to measure cardiac output There are numerous problems with using this method in severe preeclampsia These include technical difficulty inserting the catheter in an awake edematous pregnant patient potentially causing a pneumothorax damaging the carotid artery or insertion site infection There is also an increased risk for cardiac arrhythmias Apart from the risks the accuracy of the thermodilution measurements can be influenced by factors such as timing of the injection within the respiratory cycle temperature of the injectate speed of injection and placement of the catheter A readily available accurate non-invasive cardiac output measurement technique that will provide reliable data with fewer risks is needed
Doppler ultrasound trans thoracic echocardiography is the gold standard for measuring cardiac output non-invasively in pregnant patients Unfortunately the method is operator dependant not continuous and not always available when needed most
Recently a device called the FloTrac has been introduced that measures cardiac output minimally invasively Attached to an arterial line it measures cardiac output every 20 seconds via arterial waveform analysis The standard of care for measuring blood pressure in severe preeclampsia requires the placement of an intra-arterial line This group of patients is therefore ideal for measuring cardiac output with the FloTrac especially since powerful intravenous anti-hypertensives are used to control blood pressure
Our hypothesis is that the FloTrac will be comparable to Doppler Ultrasound for measuring cardiac output in severely preeclamptic 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-0078-E | None | None | None |