Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518980
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Prospective Validation of Intraoperative Blood Pressure Monitors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Validation of Intraoperative Blood Pressure Monitors the Influence of Site and Execution Strategy The PROMISES Trial
Status:
NOT_YET_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:
PROMISES
Brief Summary:
This observational study aims to identify the incidence and importance of discrepancies between measurements of intraoperative invasive and noninvasive blood pressure monitoring in patients undergoing non-cardiac surgeries under general anesthesia The main questions it aims to answer are
The importance of the differences in mmHg between the non-invasive and invasive blood pressure measurements NIBP-IBP on systolic diastolic and mean arterial pressure
Identify the predictive factors associated with these differences
The importance of the differences in mmHg between the non-invasive and invasive blood pressure measurements NIBP-IBP on systolic diastolic and mean arterial pressure
Identify the predictive factors associated with these differences
Detailed Description:
The monitoring of arterial blood pressure invasively or noninvasively is a requirement for perioperative hemodynamic and anesthesia management to optimize the administration of fluids and vasopressors Numerous trials have highlighted the consequences of intraoperative blood pressure variability regarding the risk of serious complications and postoperative mortality associated with organ ischemia and bleeding Precisely intraoperative hypotension MAP 65 mm Hg has been associated with cardiac complications as well as acute kidney injury While no optimal intraoperative blood pressure targets has been established to minimize perioperative complications a recent comprehensive literature review established recommended mean arterial pressure MAP and blood pressure BP targets within 100 to 120 of BP baseline with MAP 60 mm Hg if the patient presented low baseline systolic BP 90 mm Hg or diastolic BP 50 mm Hg and MAP within 90 to 110 BP baseline and 65 to 95 mm Hg for normal baseline systolic BP 90-129 mm Hg and diastolic BP 50-79 mm Hg patients
Invasive blood pressure monitoring by arterial catheterization is the gold standard in intraoperative hemodynamic management While providing continuous blood pressure readings allowing for dynamic and constant monitoring clinically relevant transducer inaccuracies have been documented present in up to 30 of patients Within patients of the same study comparison of invasive and noninvasive blood pressure demonstrated considerable overestimation of systolic blood pressure and underestimation of diastolic blood pressure
Oscillometric blood pressure monitoring is noninvasive quick and effortlessDespite its convenience the oscillometric monitoring of blood pressure does not allow for continuous blood pressure measurement possibly delaying or missing the recognition of hypotensive episodes Moreover oscillometric devices can tend to inaccurately measure blood pressure in comparison to invasive monitoring methods In intraoperative and critical care settings studies have shown oscillometric devices tendencies to overestimate low blood pressure failing to accurately detect hypotensive episodes thus demonstrating the superiority of invasive monitoring methods
The discrepancies between invasive and noninvasive methods of blood pressure monitoring have been described in prior studies It has been determined that noninvasive blood pressure tended to be greater than invasive blood pressure in 561 of systolic measurements and 673 of diastolic measurements for the same patient Furthermore noninvasive blood pressure readings tend to overestimate mean arterial pressure for low blood pressure values and to underestimate mean arterial pressure for high blood pressure values
Considering the consequences associated with even short intraoperative hypotensive episodes the discrepancies between noninvasive and invasive blood pressure monitoring are not negligible Currently little is known about the relation between these discrepancies and contextual elements linked to the patient or the surgery
Therefore this prospective observational trial aims to identify the incidence of gradients between intraoperative noninvasive and invasive blood pressure monitoring and extract key relationships between the occurrence of these gradients and the patients comorbidity profile the monitors parameters and artifacts and the perioperative chronology
Study duration 12 months
Study Center Maisonneuve-Rosemont Hospital Integrated University Health and Social Services Centre CIUSSS de lEst de lIle de Montreal CEMTL University of Montreal Montreal Quebec Canada
Adverse Events there is very little risk involved with participation in this study side effects that may be associated with the use of intra-radial canula for invasive blood pressure measurement
Invasive blood pressure monitoring by arterial catheterization is the gold standard in intraoperative hemodynamic management While providing continuous blood pressure readings allowing for dynamic and constant monitoring clinically relevant transducer inaccuracies have been documented present in up to 30 of patients Within patients of the same study comparison of invasive and noninvasive blood pressure demonstrated considerable overestimation of systolic blood pressure and underestimation of diastolic blood pressure
Oscillometric blood pressure monitoring is noninvasive quick and effortlessDespite its convenience the oscillometric monitoring of blood pressure does not allow for continuous blood pressure measurement possibly delaying or missing the recognition of hypotensive episodes Moreover oscillometric devices can tend to inaccurately measure blood pressure in comparison to invasive monitoring methods In intraoperative and critical care settings studies have shown oscillometric devices tendencies to overestimate low blood pressure failing to accurately detect hypotensive episodes thus demonstrating the superiority of invasive monitoring methods
The discrepancies between invasive and noninvasive methods of blood pressure monitoring have been described in prior studies It has been determined that noninvasive blood pressure tended to be greater than invasive blood pressure in 561 of systolic measurements and 673 of diastolic measurements for the same patient Furthermore noninvasive blood pressure readings tend to overestimate mean arterial pressure for low blood pressure values and to underestimate mean arterial pressure for high blood pressure values
Considering the consequences associated with even short intraoperative hypotensive episodes the discrepancies between noninvasive and invasive blood pressure monitoring are not negligible Currently little is known about the relation between these discrepancies and contextual elements linked to the patient or the surgery
Therefore this prospective observational trial aims to identify the incidence of gradients between intraoperative noninvasive and invasive blood pressure monitoring and extract key relationships between the occurrence of these gradients and the patients comorbidity profile the monitors parameters and artifacts and the perioperative chronology
Study duration 12 months
Study Center Maisonneuve-Rosemont Hospital Integrated University Health and Social Services Centre CIUSSS de lEst de lIle de Montreal CEMTL University of Montreal Montreal Quebec Canada
Adverse Events there is very little risk involved with participation in this study side effects that may be associated with the use of intra-radial canula for invasive blood pressure measurement
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