Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631482
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Comparison Bewteen Intraoperative HPI vs High Mean Arterial Pressure Threshold
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial Comparing HPI and Elevated Threshold Monitor Alarms in Preventing Intraoperative Hypotension
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Intraoperative hypotension IOH is a common and serious complication during surgery closely associated with poor postoperative outcomes Traditionally anesthesiologists rely on real-time physiological parameters and alarms to monitor blood pressure but the low alarm thresholds may lead to delayed interventions The Hypotension Prediction Index HPI is a novel predictive tool that uses arterial waveform signals and advanced algorithms to forecast hypotensive events in advance Recent observational studies have shown that HPIs accuracy in predicting hypotension is highly consistent with setting the physiological monitors alarm threshold to 73 mmHg This study will compare the effectiveness of HPI and a raised alarm threshold of 73 mmHg in preventing IOH While HPI is promising with its AI-assisted approach to patient care its high cost due to the advanced technology raises concerns If its accuracy is comparable to simply raising the traditional monitor threshold it may not lead to substantial changes in clinical practice
Detailed Description:
Intraoperative hypotension IOH is a significant complication that affects surgical patients potentially leading to adverse outcomes postoperatively Standard practices involve relying on monitoring devices with low alarm thresholds for blood pressure which may result in delayed interventions The Hypotension Prediction Index HPI offers a predictive approach by analyzing arterial waveform signals and using complex algorithms to detect potential hypotensive episodes early Recent observational studies have suggested that HPIs accuracy in predicting hypotension aligns closely with raising the physiological monitor alarm threshold to 73 mmHg To further investigate this this study will compare the effects of setting a traditional monitor alarm threshold at 73 mmHg with using HPI to prevent IOH
In this study patients will be randomly assigned to two groups In the HPI group interventions will be initiated when the HPI value exceeds 85 These interventions will follow a protocol that includes fluid administration norepinephrine and dobutamine to prevent hypotension The control group will have their alarm threshold set at 73 mmHg For these patients interventions will be based on stroke volume variation SVV and clinical judgment utilizing fluid and norepinephrine as needed HPI is an attractive AI-based tool for medical care but its high cost due to advanced technology raises questions If its accuracy proves to be similar to simply raising the alarm threshold to 73 mmHg it may not lead to meaningful changes in clinical practice The study aims to compare the efficacy of these two methods in reducing the incidence of IOH
In this study patients will be randomly assigned to two groups In the HPI group interventions will be initiated when the HPI value exceeds 85 These interventions will follow a protocol that includes fluid administration norepinephrine and dobutamine to prevent hypotension The control group will have their alarm threshold set at 73 mmHg For these patients interventions will be based on stroke volume variation SVV and clinical judgment utilizing fluid and norepinephrine as needed HPI is an attractive AI-based tool for medical care but its high cost due to advanced technology raises questions If its accuracy proves to be similar to simply raising the alarm threshold to 73 mmHg it may not lead to meaningful changes in clinical practice The study aims to compare the efficacy of these two methods in reducing the incidence of IOH
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