Clinical Trials Logo
  1. Home
  2. Intraoperative Hypotension
  3. NCT05101590

Hypotension Decision Assist - Use, Safety and Efficacy — HDA-USE  

Intraoperative Hypotension Clinical Trial

Official title:
A Study of the Use, Safety and Efficacy of the Hypotension Decision Assist Device

Clinical Trial Summary

This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.

Clinical Trial Description

In this study participants who are due to undergo elective major surgery and have an arterial line as part of their standard care will be invited to have the additional monitoring device (HDA) included as part of their care. Agreeing participants will have demographic, contact and medical history information necessary to conduct the study recorded, including a record of their intraoperative arterial line measurements. After completing the consent process participants will receive intraoperative monitoring with Hypotension Decision Assist in addition to their standard care. The HDA monitor will be attached to the patient vital signs monitor, which will in turn be attached to the blood pressure transducer. All sampled arterial line data collected by the patient vital signs monitored will be automatically transmitted in real time to the HDA device via a serial cable attached to a digital export port of the vital signs monitor. HDA will process this input data to display, in graphical and numeric format, vital signs data and physiological parameters derived from the arterial wave form data including: Mean Arterial Pressure (MAP), systolic and diastolic blood pressure, heart rate and changes in heart rate, cardiac output and systemic vascular resistance. The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device and to evaluate whether HDA improves control of the cardiovascular system from the anaesthetists' perspective. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05101590
Study type Interventional
Source Directed Systems Limited
Contact
Status Completed
Phase N/A
Start date October 22, 2021
Completion date February 28, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT04519203 - The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery N/A
Recruiting NCT05011357 - Phenylephrine and Pulse Pressure Variability Early Phase 1
Completed NCT04025086 - Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position
Completed NCT03965793 - Individualized Fluid And Vasopressor Administration In Surgical Patients N/A
Recruiting NCT05557253 - Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery N/A
Completed NCT04547491 - Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery N/A
Completed NCT03376347 - Intraoperative Implementation of the Hypotension Probability Indicator N/A
Recruiting NCT06091904 - Effects of Sufentanil on the Intraoperative Hemodynamics N/A
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Recruiting NCT06202638 - Hypotension Prediction Index (HPI) in Lung Resections
Completed NCT04301102 - The Predict H Trial N/A
Completed NCT05671783 - Intraoperative Hypotension and Post-anesthesia Care Unit Recovery
Completed NCT05821647 - Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission N/A
Recruiting NCT04872504 - Hypotension Prediction Index in Patients Undergoing Liver Transplantation N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury
Recruiting NCT05637606 - HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery N/A
Completed NCT03889730 - Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery
Completed NCT03442907 - Personalized Blood Pressure Management N/A
Recruiting NCT03795831 - Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
Recruiting NCT05341167 - HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH] N/A