Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316817
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-27
Brief Title:
FloPatch for Prevention of Hypotension After Induction of General Anesthesia
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Prediction of Hypotension After Induction of General Anesthesia Using Wearable Carotid Artery Doppler Ultrasound Patch in Adult Patients Undergoing Elective Noncardiac Surgery a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
HI-CAP
Brief Summary:
This study is being conducted to find out if a special device called FloPatch which sticks to a persons skin and uses ultrasound to check the blood flow in their neck can tell if someone going to have low blood pressure after they get put to sleep for surgery The investigators will be testing this in adults who are having elective non-heart surgery Basically the goal is to see if this device can help predict who might have low blood pressure during surgery
Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality Even short durations of intraoperative hypotension have been associated with acute kidney injury AKI and myocardial injury Myocardial injury after non-cardiac surgery MINS is a common postoperative complication associated with adverse cardiovascular outcomes and intraoperative hypotension is believed to be involved in its development
In the preoperative setting a systematic review of 50 studies 2260 patients evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive pointing to volume status as a significant risk factor while also presenting a challenge in distinguishing fluid-responders from non-responders For surgical patients preoperative fasting hypertonic bowel preparations anesthetic agents and positive pressure ventilation all contribute to reduced effective circulating blood volume Optimized fluid therapy remains the cornerstone of treatment of hypovolemia with excellent effectiveness Since the liberal use of fluids may result in fluid overload which is associated with the development of pulmonary edema wound infection postoperative ileus and anastomotic leakage it is imperative to identify those patients who may benefit from it
The hypothesis is that the corrected Flow Time cFT measured by the FloPatch will help predict hypotension after the induction of general anesthesia
Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality Even short durations of intraoperative hypotension have been associated with acute kidney injury AKI and myocardial injury Myocardial injury after non-cardiac surgery MINS is a common postoperative complication associated with adverse cardiovascular outcomes and intraoperative hypotension is believed to be involved in its development
In the preoperative setting a systematic review of 50 studies 2260 patients evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive pointing to volume status as a significant risk factor while also presenting a challenge in distinguishing fluid-responders from non-responders For surgical patients preoperative fasting hypertonic bowel preparations anesthetic agents and positive pressure ventilation all contribute to reduced effective circulating blood volume Optimized fluid therapy remains the cornerstone of treatment of hypovolemia with excellent effectiveness Since the liberal use of fluids may result in fluid overload which is associated with the development of pulmonary edema wound infection postoperative ileus and anastomotic leakage it is imperative to identify those patients who may benefit from it
The hypothesis is that the corrected Flow Time cFT measured by the FloPatch will help predict hypotension after the induction of general anesthesia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None