Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
NCT Number: NCT06316817
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 (2,260 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.
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Notify Me18 year and older
All sexes
Observational
Toronto, Ontario, M5G 1X5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A novel, hands-free ultrasound patch for continuous monitoring of quantitative Doppler in the carotid artery.
Time frame: within 20 minutes after induction
The primary outcome is the performance characteristics of the preoperative common carotid artery corrected Flow Time (cFT) to predict Post Induction Hypotension(PIH). PIH will be defined as MAP below an absolute threshold of 65 mmHg or relative threshold of 25% decrease from baseline4 (defined as the first preoperative blood pressure measurement on the morning of surgery), within 20 minutes after induction.
Time frame: The duration of the surgery
To determine the ability of the change in common carotid artery corrected Flow Time(cFT) during passive leg raising (PLR) and after PLR in predicting Post Induction Hypotension(PIH).
Time frame: The duration of the surgery.
To determine the optimal thresholds for a preoperative common carotid artery corrected Flow Time (cFT) change during PLR, in predicting Post Induction Hypotension(PIH).
Time frame: The duration of the surgery.
To determine the optimal thresholds for a preoperative common carotid artery corrected Flow Time(cFT), after Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH).
Time frame: The duration of the surgery.
To assess the time required to acquire preoperative common carotid artery corrected Flow Time(cFT) data in patients presenting to surgery.
Time frame: The duration of the surgery.
To determine if common carotid artery corrected Flow Time(cFT) measurements taken during the time of anesthetic induction correlate with the occurrence of Post Induction Hypotension(PIH).
Mount Sinai Hospital, Canada
Other
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
Acronym: HI-CAP
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