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Postoperative Complications clinical trials

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NCT ID: NCT06323616 Recruiting - Anesthesia Clinical Trials

The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care. Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation. In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of >12 points for the diagnosis of ED is 100% and the specificity is 94.5%. Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics. There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.

NCT ID: NCT06319209 Active, not recruiting - Breast Cancer Clinical Trials

Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection

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

Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors.

NCT ID: NCT06318793 Completed - Clinical trials for Peritoneal Carcinomatosis

Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis

Start date: September 2012
Phase:
Study type: Observational

A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study. During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist. Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was < 0.05. Statistical analyses were performed using R software (version 4.0.5).

NCT ID: NCT06298435 Not yet recruiting - Clinical trials for Postoperative Complications

Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements

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

• Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings. Main research question - To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes - Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex. - Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes.

NCT ID: NCT06296277 Not yet recruiting - Surgery Clinical Trials

Mechanical Ventilation in Surgical Patients

MEET VENUS
Start date: June 1, 2024
Phase:
Study type: Observational

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation. Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

NCT ID: NCT06295042 Completed - Quality of Life Clinical Trials

Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction

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

Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective. This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction.

NCT ID: NCT06294769 Not yet recruiting - Acute Pain Clinical Trials

Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial

Start date: March 18, 2024
Phase: N/A
Study type: Interventional

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.

NCT ID: NCT06292910 Completed - Clinical trials for Congenital Heart Disease

Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery

VACO2
Start date: August 8, 2021
Phase:
Study type: Observational

The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial. The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research

NCT ID: NCT06289699 Recruiting - Clinical trials for Postoperative Complications

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

Start date: February 26, 2024
Phase:
Study type: Observational

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

NCT ID: NCT06276140 Not yet recruiting - Colorectal Cancer Clinical Trials

Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

ID-COLO
Start date: April 2024
Phase:
Study type: Observational

The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are: - whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery - whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients. Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin. Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected. The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.