Clinical Trials Logo

Clinical Trial Summary

This study is being conducted to find out if a special device called FloPatchâ„¢, 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06316817
Study type Observational
Source Mount Sinai Hospital, Canada
Contact James Khan, MD
Phone (416) 586-5270
Email james.khan@medportal.ca
Status Not yet recruiting
Phase
Start date April 1, 2024
Completion date March 2, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05497700 - Comparative Efficacity of Ephedrine Versus Norepinephrine to Correct Anesthesia Induction Related Hypotension Phase 3
Not yet recruiting NCT03580590 - Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery Early Phase 1
Completed NCT04573842 - Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Recruiting NCT06426784 - Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
Completed NCT04603469 - Hypotension in Children With Down Syndrome With Anesthesia Induction
Recruiting NCT05891951 - Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery N/A
Completed NCT05842759 - Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study N/A
Recruiting NCT05884918 - Intraoperative Hypotension in High-risk Patients Undergoing Surgery
Completed NCT05239234 - Ultrasonographic Predictors of Hypotension After Induction
Not yet recruiting NCT04291794 - Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion Phase 4
Completed NCT04051073 - Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study. Phase 3
Completed NCT01669434 - Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery Phase 4
Completed NCT05424510 - PoCUS Guided Fluids to Prevent Post-induction Hypotension N/A
Recruiting NCT05969886 - Ventricular-Arterial Coupling: A Predictor of Post-Induction Hypotension
Not yet recruiting NCT05536323 - Bolus Versus Continuous Remimazolam for Anesthetic Induction N/A
Recruiting NCT03237429 - The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
Withdrawn NCT04299776 - CirQPOD Shoulder Study N/A
Completed NCT03439007 - Anesthesia-induced Hypotension and Fluid Responsiveness
Completed NCT03787732 - Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation Phase 4
Not yet recruiting NCT05960604 - Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients