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Hemodynamic Monitoring clinical trials

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NCT ID: NCT05202769 Recruiting - Clinical trials for Hemodynamic Monitoring

Non-Invasive Vital Signs Monitoring (NIVS) Project

NIVS
Start date: February 11, 2022
Phase:
Study type: Observational

This study is aimed at non-invasive extraction of cardiovascular and respiratory parameters from red-green-blue (RGB) and thermal imaging cameras from patients in the intensive care unit (ICU) setting. The main focus of this study is in assessing the feasibility of implementing such a camera-based system for prolonged monitoring of patients, identifying limiting factors which may interfere with accuracy or practical aspects of the system, and postulating solutions to overcoming these.

NCT ID: NCT04996420 Terminated - Clinical trials for Arthroplasty, Replacement, Hip

Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty

Start date: May 22, 2019
Phase: N/A
Study type: Interventional

Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability. The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring. The primary endpoint is to evaluate total duration of hypotension, defined as a MAP < 65 mmHg, calculated during all the perioperatory time. Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.

NCT ID: NCT04972266 Completed - Clinical trials for Hemodynamic Monitoring

The EU Hyprotect Registry

Start date: September 28, 2021
Phase:
Study type: Observational [Patient Registry]

European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery

NCT ID: NCT04858126 Completed - Clinical trials for Hemodynamic Monitoring

Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.

NCT ID: NCT04648293 Completed - Clinical trials for Hemodynamic Monitoring

Starling Registry Study

Start date: November 16, 2020
Phase:
Study type: Observational [Patient Registry]

Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications. As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management. This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.

NCT ID: NCT04535115 Completed - Clinical trials for Hemodynamic Monitoring

Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness.

TIDALEC
Start date: November 15, 2020
Phase: N/A
Study type: Interventional

In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM). The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.

NCT ID: NCT04517409 Completed - Clinical trials for Hemodynamic Monitoring

Goal-directed Hemodynamic Therapy in Patiens Undergoing Major Hepatic Resection

GOAL-HEMO
Start date: November 5, 2015
Phase: N/A
Study type: Interventional

The aim of the study of patients undergoing major hepatic resection was compared standard perioperative (control Group) with hemodinamic management based on PPV, VVS, continuos CO trending and dynamic arterial elastance using radial artery pulse contour analysis (GDHT group). We hypothessized that following this treatment regimen after hepatic resection results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secundary endpoint)

NCT ID: NCT04369027 Recruiting - Clinical trials for Hemodynamic Monitoring

Changes of Pulse Pressure Variation Duing Tidal Volume Challenge in Patients With Spontaneous Breathing

Start date: January 6, 2019
Phase:
Study type: Observational

Background: Predicting preload responsiveness by using dynamic indicators before administering fluids to critically ill patients is nowadays routinely performed at the bedside. Unlike other dynamic indicators of preload responsiveness that require cardiac output monitoring, pulse pressure variation (PPV) can be simply obtained via an arterial catheter . However, PPV is not reliable in mechanically ventilated patients with spontaneous breathing activity. We hypothesized that an increase in PPV after a tidal volume (TV) challenge (TVC) or a decrease in PPV during passive leg raising (PLR) will predict preload responsiveness in such cases. Objective: to examine if the change in PPV during PLR and after a TVC can predict preload responsiveness in patients with mechanical ventilation and persistent spontaneous breathing

NCT ID: NCT04362033 Recruiting - Clinical trials for Coronary Artery Bypass Grafting

Comparison of Dynamic Fluid Responsiveness by EIT and Transpulmonary Thermodilution in Postoperative of CABG Patients

Start date: August 22, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Patients will be hemodinamically monitored with the VolumeView set in combination with EV1000 clinical platform and the display of valuable volumetric parameters (Edwards Lifesciences, California, USA). Simultaneoulsy, patients will be monitored with Enlight Electrical Impedance Tomography (Timpel, São Paulo, Brazil). Hemodynamic data will be assessed at baseline 1, one minute after the passive leg raising maneuver, after PEEP increment, and after 500 mL of Lactated Ringer's (bolus infusion). Blood gases sample will be assessed before and immediatly after the protocol.

NCT ID: NCT04281771 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI

APPOSE
Start date: September 17, 2019
Phase: N/A
Study type: Interventional

Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively common and there is conflicting evidence regarding the clinical impact of mild paravalvular leakage in self-expanding devices. Prospective data for self-expanding devices are required to compare the extent of paravalvular leakage as a result of device design. Grading paravalvular leakage after TAVI is difficult. Echocardiography and angiography systematically underestimate paravalvular leakage (PVL) as compared to cardiac MRI. Hemodynamic measurements are used to aid decision making directly after TAVI implantation. Prospective data comparing hemodynamic measurements with cardiac MRI are needed to design an optimal strategy to grade paravalvular leakage peri-operatively in order to optimize TAVI outcomes. The combination of aortic valve stenosis, angiodysplasia and von Willebrand Disease type 2A (vWD-2A) is known as Heyde syndrome. Previous studies have shown a decrease in angiodysplastic lesions after TAVI. However, since PVL after TAVI is relatively common, angiodysplastic lesions tend to reoccur. Prospective data comparing the severity of PVL to the severity of both vWD-2A and angiodysplasia are lacking. Objective: To assess procedural hemodynamic measurements in patients with paravalvular regurgitation quantified by means of cardiac MRI (CMR) and to analyse its association with impaired clinical outcome during 5-year follow-up. Secondary objectives are to assess whether the severity of vWD-2A correlates with the severity of PVL measured by cardiac MRI, and to prospectively assess the success percentage of TAVI in the treatment of angiodysplasia. Study design: This is a prospective, single-center clinical trial. Patients will receive a TAVI. After implantation different hemodynamic indices of PVL will be assessed. Within 4-8 weeks after TAVI a cardiac MRI will be performed to quantify the amount of PVL. Standardized clinical follow-up will take place at discharge, 30 days, 3 months, 6 months and 1 year. Telephone follow-up will take place at 2, 3, 4 and 5 years after TAVI. In patients with known angiodysplasia or iron deficiency anemia e.c.i., a videocapsule endoscopy (VCE) will take place before TAVI and 6 months after TAVI. Of note, for the substudy on Heyde syndrome, patients with a different type of TAVI valve (i.e. no Abbott Portico valve) are also allowed to participate. Study population: Approximately 80 patients with severe symptomatic aortic valve stenosis with an indication for TAVI will be included. At least 76 patients with a cardiac MRI that is of sufficient quality to quantify the amount of PVL will be included. Intervention: Patients will undergo cardiac MRI on top of standard clinical care within 4-8 weeks after TAVI. A subgroup of patients will also undergo a VCE. Main study parameters/endpoints: The primary endpoint is defined as PVL regurgitation fraction as measured by cardiac MRI. One secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) (1) and will comprise death, vascular complications, stroke/TIA, life-threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis. Another secondary endpoint will be the reduction of angiodysplastic lesions after TAVI as determined by VCE. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The hemodynamic indices can be assessed in a standard fashion using a fluid filled pigtail catheter that is placed in the left ventricle as part of the routine protocol. Following TAVI, enrolled patients will undergo cardiac MRI to assess PVL. The risk of cardiac MRI after TAVI implantation is negligible. Extra blood samples will be taken. After one year, patients will be followed by telephonic follow-up. Risk/benefit: the expected benefit is a structured clinical follow-up at 1, 2, 3, 4 and 5 years, at the cost of an extra visit to undergo cardiac MRI.