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Vascular Surgery clinical trials

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NCT ID: NCT06248775 Recruiting - Type 2 Diabetes Clinical Trials

Nursing Prehabilitation Intervention Supported With Technology for Vascular Surgery in People With Type 2 Diabetes

VITAAAL
Start date: November 16, 2023
Phase: N/A
Study type: Interventional

Type 2 Diabetes Mellitus (T2DM) is the most common chronic lifestyle-related disorder with a significant impact on quality and healthcare expenditures. Insufficient glycemic control and low fitness level prior to a surgical intervention results in more postoperative complications which leads to a longer hospitalization, higher costs and mortality. A prehabilitation intervention in persons with T2DM prior to surgery should be aimed to improve glucose regulation and translate into better outcomes. However, the classic interventions such as Combined Lifestyle Intervention are labor-intensive and require a high degree of organization and therefore are not used as standard care. The use of biofeedback can provide a solution to this. Biofeedback with a continuous glucose sensor in combination with lifestyle monitoring by activity trackers and coaching prior to surgery is a promising but unexplored prehabilitation strategy. The Nursing Prehabilitation Intervention Supported with Technology for vascular Surgery in People with Type 2 Diabetes (VITAAAL) intervention is a form of blended care. It focuses on improving vitality and glycemic control before surgery with the Diameter application, using intermittently scanned glucose monitoring, nutrition habits and physical activity blended with coaching from a nurse practitioner (NP) diabetes. Because VITAAAL is a novel intervention, the aim of this pilot study is to investigate its usability and feasibility. The pilot study consists of three phases. After the first phase, a specific prehabilitation module will be designed and programmed in the Diameter app. This module will be based on the results and experiences in phase one. In phase two and three the patients will use the adjusted version of the Diameter app that contains implemented findings of the previous phase.

NCT ID: NCT06159517 Recruiting - Cardiac Surgery Clinical Trials

Heart Lung Machine Registry

HeaLMe
Start date: December 21, 2023
Phase:
Study type: Observational

The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing cardiac / thoracic / vascular surgery.

NCT ID: NCT05968456 Recruiting - Anesthesia Clinical Trials

Complexity and Frailty in Cardiothoracic and Vascular Anesthesia (CAfCA). Prospective Multicentric Observational Study

CAfCA
Start date: October 10, 2023
Phase:
Study type: Observational

Frailty is a multidimensional syndrome characterized by a decline in physiological homeostatic reserve, which translates into an increased susceptibility to adverse events and unfavorable outcomes following even small exposures to physical, physiological or psychosocial stress. In the European population up to 69 years, the prevalence is generally 6,5%, beyond 85 years of age it exceeds 50% and reaches 65% in the over-ninety population. The prevalence of frailty in the surgical population varies, depending on the studies, from 10 to 40%. Frailty and its severity grade represent themselves noticeably as strong predictors of adverse postoperative outcomes. The strongest evidence of association is recorded between frailty and mortality at 30 days. The purpose of this study is to describe the characteristics of patients undergoing anesthesia for cardiothoracic and vascular surgery, with a specific focus on frailty elements and associated comorbidities that necessitate surgery. This data analysis will provide valuable insights into the interaction between frailty, multimorbidity, and the perioperative pathway of patients undergoing cardiothoracic and vascular anesthesia.

NCT ID: NCT05614869 Recruiting - Abdominal Surgery Clinical Trials

Continuous Treatment With PREVENA Therapy for 14 Days

Start date: February 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate substantial equivalence in terms of safety to support an indication change related to the usage of Prevena Therapy for up to 14 days. The enrolled subject will undergo 1 of 4 surgery types and be evaluated for up to 90 days.

NCT ID: NCT03926104 Recruiting - General Anesthesia Clinical Trials

BNP and Vascular Surgery

BNPinVasc
Start date: December 10, 2018
Phase:
Study type: Observational

Background and rationale of the study: Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types. An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery. To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels. BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia. So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management. This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.

NCT ID: NCT03883763 Recruiting - Spinal Anesthesia Clinical Trials

Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery. The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).

NCT ID: NCT02863250 Recruiting - Trauma Clinical Trials

Australian and New Zealand Massive Transfusion Registry

ANZ-MTR
Start date: March 2011
Phase:
Study type: Observational [Patient Registry]

Severe and un-stopped blood loss can occur for a number of different reasons including after a serious injury, delivery of a baby and following other medical and surgical emergencies. The investigators understanding of how to best treat people with serious bleeding is still incomplete, with many questions remaining. These include questions regarding how many people have serious bleeding events, what happens to them and the best way to treat them. The Massive Transfusion Registry (MTR) is a register of patients who have experienced major blood loss that required a massive transfusion in any clinical setting. The MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical data from hospital data sources, including Laboratory Information Systems (for transfusion history and laboratory results) and Health Information Services databases (for Patient demographics and admission data), are electronically extracted by staff employed at the participating hospitals. The data is then sent to the MTR Research Team, located at Monash University, where it is then linked, analysed and stored. The establishment of a Massive Transfusion Registry will be a unique and important resource for clinicians in Australia, New Zealand and internationally, for Blood Services and for the broader community. It will provide valuable observational data regarding the types and frequency of conditions associated with critical bleeding requiring massive transfusion, the use of blood component therapy (i.e. ratios and quantities of different types of red cell to non- red cell components) and patient outcomes.