Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804773
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-03-27
Brief Title:
Cerebral Perfusion Variation During Blood Pressure Changes in ICU
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Cerebral Perfusion Variation During Blood Pressure Changes in ICU Relationship Between Transcranial Doppler Frontal EEG and Cerebral Oximetry a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
DELTAPAMREA
Brief Summary:
The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension associated abnormalities HR cardiac output and oxygen transport and the patients terrain
Currently a mean arterial pressure greater than 60 mm Hg 1 and a reduction of less than 30-50 from the value measured before sedation are commonly used to ensure good perfusion of all organs In intensive care it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure CPP 50 mmHg for neurocompromised patients with Intra Cranial pressure ICP measure Normally cerebral blood flow is self-regulated allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure However this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient
The aim of the study is to measure non-invasively easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit
What is the tolerable target BP level for a patient under continuous sedation in the ICU Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially the adequacy of the brains oxygen requirements
Currently a mean arterial pressure greater than 60 mm Hg 1 and a reduction of less than 30-50 from the value measured before sedation are commonly used to ensure good perfusion of all organs In intensive care it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure CPP 50 mmHg for neurocompromised patients with Intra Cranial pressure ICP measure Normally cerebral blood flow is self-regulated allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure However this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient
The aim of the study is to measure non-invasively easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit
What is the tolerable target BP level for a patient under continuous sedation in the ICU Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially the adequacy of the brains oxygen requirements
Detailed Description:
The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension associated abnormalities HR cardiac output and oxygen transport and the patients terrain
Currently a mean arterial pressure greater than 60 mm Hg 1 and a reduction of less than 30-50 from the value measured before sedation are commonly used to ensure good perfusion of all organs In intensive care it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure CPP 50 mmHg for neurocompromised patients with Intra Cranial pressure ICP measure Normally cerebral blood flow is self-regulated allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure However this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient
The aim of the study is to measure non-invasively easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit Cerebral perfusion and cerebral O2 adequacy will be compared and assessed by continuous and simultaneous measurements of cerebral blood flow by transcranial Doppler CTD cerebral O2 adequacy by near-infrared spectroscopy NIRS and a parameter of cerebral function by electroencephalogram EEG - frontal EEG
The objective for a given patient is to detect a possible threshold pressure value that could impact blood flow velocity Doppler and possibly EEG and cerebral oximetry
This clinical research is carried out on adult patients hospitalized in intensive care Their non-opposition to participate in this study will be collected during the hospitalization or if necessary the trusted personrelative of a patient unable to express hisher will The protocol starts after at least 12 hours of stablisation in the intensive care unit
All measurements are obtained non-invasively Monitoring includes routine continuous electrocardiogram and blood pressure monitoring by non-invasive Clearsight EV1000 Edwards Sciences or invasive means if already in place pulsed O2 saturation SpO2 ventilatory parameters RR VC FiO2 and depth of sedation by frontal EEG
In the ICU patients are sedated according to the usual protocol with midazolam or propofol and sufentanil with vasopressor support by norepinephrine Adjustment of the blood pressure level during routine care allows to obtain mean arterial pressure levels adapted to the patients situation and comorbidities
In our current practice
- when blood pressure stability is obtained the dose of norepinephrine is progressively decreased to a MAP target 70 of the baseline value without never going below 60 mmHg for patients without low cardiovascular risk factors and 80 mmHg for patients with cardiovascular risk factors or a cerebral perfusion pressure CPP 50 mmHg for neurocerebral injury patients monitored by an intracranial pressure ICP
Patients over 18 years old are eligible to participate in this protocol For ICU patients monitoring of the depth of anesthesia using a quantitative frontal EEG Sedline Masimo ensures continuous recording of intraoperative EEG data Placement of a frontal O3 Sensor rSO2 Masimo or Foresight sensor rSO2 Edwards electrode for continuous measurement of cerebral tissue O2 saturation StO2 Continuous measurement of blood velocity in the middle cerebral artery by transcranial pulsed Doppler TCD Atys Medical TCD-X The probe attachment system on the patients head is similar to a pair of glasses it is light and comfortable The orientation of the robotic probe is automatically readjusted to ensure stable recording quality over time
No additional examinations will be performed The physician in charge of the study collecting the data is not involved in the patients management at any time
The monitoring data are currently available and are made available in the clinical research unit of our department using
A data extraction system from the PHILIPS IntelliVue monitoring solutions The Data Warehouse Connect software solution allows the collection of all these data with a fine sampling 2ms for the tracings 1s for the numerical data which considerably widens the capacities in terms of data analysis and exploitation
The extraction system is temporally coupled to the events that occur to the patient the drugs doses administered thanks to an information system IntelliSpace Critical Care and Anesthesia ICCAA
The physician in charge of the study collecting the data does not participate at any time in the management of the patient The measures cannot influence the prescribing physician since at this stage the data are not yet analyzed and available
Our main objective is to identify a significant linear relationship between the percentage change in mean velocity Vm and the percentage change in the 95 spectral frequency front SEF95 during the MAP change
We seek to reject the null hypothesis based on the R2 measure of goodness of fit H0 R2 0
Considering a type I error probability 005 and a power of 85 and an effect size of 03 based on preliminary data For a single predictor we obtain a sample size of n 32 patients To adjust for possible confounding factors we assume a partial correlation coefficient rho05 between Vm and the covariates This correction gives us a sample size of 322 64 patients Finally preliminary data indicate that 30 of the included patients have a poor signal or defective measurements resulting from artifacts or unsuitable experimental conditions The final number of patients to be included is estimated at N 92
Rejection of the primary null hypothesis will be established by a linear regression model
As a secondary objective linear regression will also be evaluated between Vm and EEG markers such as alpha band power time spent in burst-suppression and delta-to-alpha ratio
Descriptive statistics will be reported as n for categorical variables meanstandard deviation for continuous variables and medianIQR for ordinal variables that do not have a normal distribution
All statistical analyses will be performed using R statistical software The R Foundation for Statistical Computing Vienna Austria Results will be expressed as means standard deviation A p-value of less than 005 is considered significant
Currently a mean arterial pressure greater than 60 mm Hg 1 and a reduction of less than 30-50 from the value measured before sedation are commonly used to ensure good perfusion of all organs In intensive care it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure CPP 50 mmHg for neurocompromised patients with Intra Cranial pressure ICP measure Normally cerebral blood flow is self-regulated allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure However this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient
The aim of the study is to measure non-invasively easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit Cerebral perfusion and cerebral O2 adequacy will be compared and assessed by continuous and simultaneous measurements of cerebral blood flow by transcranial Doppler CTD cerebral O2 adequacy by near-infrared spectroscopy NIRS and a parameter of cerebral function by electroencephalogram EEG - frontal EEG
The objective for a given patient is to detect a possible threshold pressure value that could impact blood flow velocity Doppler and possibly EEG and cerebral oximetry
This clinical research is carried out on adult patients hospitalized in intensive care Their non-opposition to participate in this study will be collected during the hospitalization or if necessary the trusted personrelative of a patient unable to express hisher will The protocol starts after at least 12 hours of stablisation in the intensive care unit
All measurements are obtained non-invasively Monitoring includes routine continuous electrocardiogram and blood pressure monitoring by non-invasive Clearsight EV1000 Edwards Sciences or invasive means if already in place pulsed O2 saturation SpO2 ventilatory parameters RR VC FiO2 and depth of sedation by frontal EEG
In the ICU patients are sedated according to the usual protocol with midazolam or propofol and sufentanil with vasopressor support by norepinephrine Adjustment of the blood pressure level during routine care allows to obtain mean arterial pressure levels adapted to the patients situation and comorbidities
In our current practice
- when blood pressure stability is obtained the dose of norepinephrine is progressively decreased to a MAP target 70 of the baseline value without never going below 60 mmHg for patients without low cardiovascular risk factors and 80 mmHg for patients with cardiovascular risk factors or a cerebral perfusion pressure CPP 50 mmHg for neurocerebral injury patients monitored by an intracranial pressure ICP
Patients over 18 years old are eligible to participate in this protocol For ICU patients monitoring of the depth of anesthesia using a quantitative frontal EEG Sedline Masimo ensures continuous recording of intraoperative EEG data Placement of a frontal O3 Sensor rSO2 Masimo or Foresight sensor rSO2 Edwards electrode for continuous measurement of cerebral tissue O2 saturation StO2 Continuous measurement of blood velocity in the middle cerebral artery by transcranial pulsed Doppler TCD Atys Medical TCD-X The probe attachment system on the patients head is similar to a pair of glasses it is light and comfortable The orientation of the robotic probe is automatically readjusted to ensure stable recording quality over time
No additional examinations will be performed The physician in charge of the study collecting the data is not involved in the patients management at any time
The monitoring data are currently available and are made available in the clinical research unit of our department using
A data extraction system from the PHILIPS IntelliVue monitoring solutions The Data Warehouse Connect software solution allows the collection of all these data with a fine sampling 2ms for the tracings 1s for the numerical data which considerably widens the capacities in terms of data analysis and exploitation
The extraction system is temporally coupled to the events that occur to the patient the drugs doses administered thanks to an information system IntelliSpace Critical Care and Anesthesia ICCAA
The physician in charge of the study collecting the data does not participate at any time in the management of the patient The measures cannot influence the prescribing physician since at this stage the data are not yet analyzed and available
Our main objective is to identify a significant linear relationship between the percentage change in mean velocity Vm and the percentage change in the 95 spectral frequency front SEF95 during the MAP change
We seek to reject the null hypothesis based on the R2 measure of goodness of fit H0 R2 0
Considering a type I error probability 005 and a power of 85 and an effect size of 03 based on preliminary data For a single predictor we obtain a sample size of n 32 patients To adjust for possible confounding factors we assume a partial correlation coefficient rho05 between Vm and the covariates This correction gives us a sample size of 322 64 patients Finally preliminary data indicate that 30 of the included patients have a poor signal or defective measurements resulting from artifacts or unsuitable experimental conditions The final number of patients to be included is estimated at N 92
Rejection of the primary null hypothesis will be established by a linear regression model
As a secondary objective linear regression will also be evaluated between Vm and EEG markers such as alpha band power time spent in burst-suppression and delta-to-alpha ratio
Descriptive statistics will be reported as n for categorical variables meanstandard deviation for continuous variables and medianIQR for ordinal variables that do not have a normal distribution
All statistical analyses will be performed using R statistical software The R Foundation for Statistical Computing Vienna Austria Results will be expressed as means standard deviation A p-value of less than 005 is considered significant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00059-36 | OTHER | IDRCB | None |