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Complication clinical trials

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NCT ID: NCT06146270 Not yet recruiting - Surgery Clinical Trials

Russian Registry of Surgical OutcomeS

RuSOS
Start date: March 1, 2024
Phase:
Study type: Observational

Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality. Two-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification). The study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.

NCT ID: NCT06067373 Recruiting - Complication Clinical Trials

Impact and Burden of Postponing Elective Surgeries

Start date: August 1, 2023
Phase:
Study type: Observational

Overall, little is known about the effects and burdens of postponed operations in patients with urological diseases. To investigate the consequences and develop possible strategies for overcoming these challenges, the investigators would like to evaluate the influence of operation shifts in more detail.

NCT ID: NCT06014619 Recruiting - Skin Cancer Clinical Trials

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Start date: August 1, 2023
Phase:
Study type: Observational

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

NCT ID: NCT05947136 Recruiting - Multiple Myeloma Clinical Trials

PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

PASCA -MM
Start date: January 19, 2024
Phase: N/A
Study type: Interventional

This is a prospective, multicentre, phase III, randomised, controlled intervention study. Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). - PASCA interventional group For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary. - Control group For the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management. => For all patients, regardless of group All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications: - Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment. - Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment; - Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment; - Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.

NCT ID: NCT05910931 Recruiting - Complication Clinical Trials

Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery

Start date: June 1, 2023
Phase:
Study type: Observational [Patient Registry]

During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction. Indocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values. The objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.

NCT ID: NCT05903547 Recruiting - Cesarean Section Clinical Trials

Skin Glue Cesarean Study

Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

NCT ID: NCT05835661 Recruiting - Clinical trials for Patient Satisfaction

Nasopharyngeal Airway in Obese Patients Undergoing Painless Gastroenteroscopy Compared With Transnasopharyngeal Airway

Start date: April 1, 2023
Phase:
Study type: Observational

Painless endoscopy is a popular endoscopic diagnosis and treatment method at present, and propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory center inhibition effect, leading to the decrease of blood oxygen saturation in patients, especially obese patients, more prone to blood oxygen plunge, even threatening life.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypoventilation may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, thus causing hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients.Currently, supracloglottic ventilation devices that have little impact on patients and are easy to accept are often used clinically to complete short daytime operations. The most common is the application of oropharyngeal ventilation to solve upper airway obstruction , however, oropharyngeal ventilation is inconvenient to use in gastroenteroscopy and treatment, while nasopharyngeal ventilation is suitable. However, based on the experience of observers,Although the nasopharyngeal airway can play a good role in the unobtrusived airway, the incidence of nasopharyngeal hemorrhage is high, and the comfort of patients is poor. Therefore, the researchers considered to directly insert the nasopharyngeal airway into the pharyngeal cavity next to the oral pad through the mouth, so as to achieve the effect of unobtrusived airway and increase the local oxygen concentration, and the idea of this experiment came from this.

NCT ID: NCT05807815 Completed - Clinical trials for Mechanical Ventilation Complication

The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

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

Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia. In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

NCT ID: NCT05780775 Recruiting - Sickle Cell Disease Clinical Trials

Lipid Balance in Adult Sickle Cell Patients

HDL2
Start date: November 30, 2022
Phase: N/A
Study type: Interventional

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

NCT ID: NCT05770583 Completed - Complication Clinical Trials

The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.

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

Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently. Oxygen reserve index (ORiā„¢) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia.