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Intraoperative Complications clinical trials

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NCT ID: NCT04517461 Completed - Clinical trials for Head and Neck Cancer

Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery

MVL-COAG
Start date: September 15, 2020
Phase:
Study type: Observational

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

NCT ID: NCT04410640 Completed - Surgical Injury Clinical Trials

Surgical Planning With Patient-specific Pancreaticobiliary Disease With 3D Models

Start date: July 10, 2019
Phase:
Study type: Observational

Background: Three-dimensional (3D) printing has been increasingly used in medical applications with the creation of accurate patient-specific 3D printed models in medical imaging data. However, research on 3D printing in pancreaticobiliary disease is limited with lack of studies on validation of model accuracy. Methods: This is a where general surgery residents, are introduced to 5 distinct hepatopancreatobiliary disease scenarios to generate a perception and required to compare their perception level of these cases with computed tomography (CT), 3D images and 1:1 solid models that the pathology, diverse diagnosis and presurgery diagnosis stages can be investigated.

NCT ID: NCT04182256 Completed - Clinical trials for Liver Transplant; Complications

Magnetic Spiderman for Preparation of Liver Donation

MSPLD
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Due to many vascular branches on the supra-hepatic vena cava (SHVC) and infra-hepatic vena cava (IHVC), in the whole procedures of preparation of liver donation, preparation of hepatic vena cava (HVC) is the most key and troublesome step. Magnetic Spiderman (MS) is a novel surgical instrument, designed and created to solve the vital problems of preparation of liver donation's HVC. Therefore, the aim of this study is to evaluate the feasibility and security of MS when using it prepare the liver donation's HVC.

NCT ID: NCT04020900 Completed - Anesthesia Clinical Trials

Respiratory Management of Children Under Anaesthesia

PEDIAVENT
Start date: June 21, 2017
Phase:
Study type: Observational

Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.

NCT ID: NCT03974321 Completed - Myocardial Injury Clinical Trials

Intraoperative Hypotension and Perioperative Myocardial Injury

Start date: May 1, 2019
Phase:
Study type: Observational [Patient Registry]

Acute myocardial infarction (MI) is a significant complication following non-cardiac surgery. We sought to evaluate incidence of perioperative MI, its preoperative - and intraoperative - risk factors and outcomes after this complication.

NCT ID: NCT03913650 Completed - Pain, Postoperative Clinical Trials

The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

NCT ID: NCT03901599 Completed - Anesthesia Clinical Trials

Protective Ventilation Based on Alveolar Ventilation in Children

PROVENTIPED
Start date: May 16, 2019
Phase:
Study type: Observational

Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.

NCT ID: NCT03837535 Completed - Myocardial Injury Clinical Trials

Myocardial Infarction in the Perioperative Setting

MIPS
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

Acute myocardial infarction (AMI) is a significant complication following non-cardiac surgery. The investigators sought to evaluate incidence of perioperative AMI, its preoperative and intraoperative risk factors and the outcomes after this complication.

NCT ID: NCT03697330 Completed - Clinical trials for Intraoperative Complications

Liberal Versus Restrictive Fluid Protocols in Adults

Start date: January 28, 2018
Phase: Phase 2
Study type: Interventional

The term acute kidney injury (AKI) is used to describe a rapid deterioration (hours to days) of renal function. This rapid deterioration leads to accumulation of plasma waste products, such as urea and creatinine. Accumulation of urea and other nitrogen-containing substances in the blood stream lead to a number of symptoms, such as fatigue, loss of appetite, headache, nausea and vomiting. Marked increases in the potassium level can lead to irregularities in the heartbeat, which can be severe and life-threatening. Fluid balance is frequently affected, though blood pressure can be high, low or normal. Pain in the flanks may be encountered in some conditions (such as thrombosis of the renal blood vessels or inflammation of the kidney); this is the result of stretching of the fibrous tissue capsule surrounding the kidney. Perioperative AKI is a leading cause of morbidity and mortality; It is associated with increased risk of sepsis, anemia, coagulopathy, and mechanical ventilation. The first publication of consensus criteria for AKI was published in 2004. The system was named RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) and used sCr or urine output to define AKI. Later, in 2007, a modified definition of the RIFLE criteria was published by the Acute Kidney Injury Network (AKIN) .Although the AKIN criteria evolved from the RIFLE criteria, a major advance was the understanding that even small changes in sCr concentrations are associated with increased morbidity and mortality. The AKIN criteria allowed definition of AKI even without knowledge of baseline sCr. In 2012, a clinical practice guideline of AKI was proposed by the Kidney Disease Improving Global Outcomes (KDIGO) Foundation. The guideline included a comprehensive review of AKI definition, risk assessment, diagnosis, prevention, treatment and renal replacement therapy. A common practice to maintain effective blood volume and thus kidney perfusion is intravenous (I.V.) hydration. Correcting hypovolemia is an essential perioperative hemodynamic goal and appropriate hydration is considered important for the avoidance of AKI. Perioperative fluid therapy has been studied extensively, but the optimal strategy remains controversial and uncertain. Much of the current debate surrounds the type of fluids administered (colloid versus crystalloid), the total volume administered (restrictive versus liberal), and whether the administration of fluids should be guided by hemodynamic goals (goal directed [GD] versus not goal directed). Administering a large amount of I.V. fluid in the perioperative period is a common clinical practice. Although fluid loading may expand intravascular space, improve organ perfusion or tissue oxygenation and reduce minor postoperative complications in laparoscopic surgery, excessive fluid may also increase some perioperative complications. Intraoperative urine output is often monitored but rarely responds to fluid administration. Clearance of fluid during general anesthesia is only a small fraction of that observed in conscious volunteers. Infusion of crystalloids during anesthesia shows reduced clearance and slower distribution such that intraoperative oliguria may not reflect fluid status or predict future AKI. Given that liberal fluid administration can be correlated with worse postoperative outcome, the recommendation to maintain urine output of at least 0.5 ml/kg/h should be considered.

NCT ID: NCT03617809 Completed - Clinical trials for Postoperative Complications

Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Start date: August 6, 2018
Phase:
Study type: Observational [Patient Registry]

Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult. Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using an esophagic thermometer. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.