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Perioperative Complication clinical trials

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NCT ID: NCT06445881 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment

MSJZT-NSCLC
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

Chemotherapy combined with immunotherapy is the current standard perioperative treatment for non-small cell lung cancer (NSCLC). However, this regimen has multiple side effects and shows variable efficacy among individuals. In China, adjunctive traditional Chinese medicine is widely accepted by lung cancer patients. Modified Si Jun Zi Tang, a classic formula in traditional Chinese medicine, is known for its benefits in unifying and strengthening the spleen. This study aims to evaluate whether the addition of Modified Si Jun Zi Tang to chemotherapy and immunotherapy during the neoadjuvant phase can improve the R0 resection rate, objective response rate (ORR), and safety in patients with resectable and potentially resectable NSCLC. Secondary objectives include assessing whether this combination can improve 1-year and 2-year disease-free survival (DFS) post-surgery. Additionally, we will collect relevant biological samples to identify tumor markers associated with efficacy, prognosis, and side effects, providing a theoretical basis for modernizing and standardizing traditional Chinese medicine.

NCT ID: NCT06297850 Recruiting - Diabetes Mellitus Clinical Trials

Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study

Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment. The main questions it aims to answer are: • Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment? Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.

NCT ID: NCT06270212 Recruiting - Clinical trials for Perioperative Complication

Medical Device for Airway Patency During Sedation

STAIRWAY-2
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants - of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position - of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position. PART B: Systematic evaluation (in the body position [normally supine] considered most optimal for the procedural intervention) of the cumulative duration - of adjuvant manual airway support and ventilation - of respiratory arrest (interrupted monitoring of endtidal carbon dioxide [ETCO2]) - of hypoxemia (hemoglobin saturation of oxygen [SpO2] <95 %), and - of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.

NCT ID: NCT06077422 Recruiting - Pain, Postoperative Clinical Trials

Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain

Start date: January 11, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.

NCT ID: NCT06065137 Recruiting - Hypersensitivity Clinical Trials

Standardised Drug Provocation Testing in Perioperative Hypersensitivity

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

The goal of this clinical trial is to evaluate the safety and outcome of systematic drug provocation testing with anaesthetics at therapeutic doses in adult patients undergoing diagnostic work-up for perioperative hypersensitivity.

NCT ID: NCT06035627 Recruiting - Clinical trials for Surgical Site Infection

The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.

Start date: May 15, 2023
Phase:
Study type: Observational [Patient Registry]

There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.

NCT ID: NCT06003517 Recruiting - Clinical trials for Perioperative Complication

Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data

Start date: December 10, 2022
Phase:
Study type: Observational

Based on the data from the anesthesia record electronic system, patient safety incident (PSI) electronic reporting system and related PSI retrospective cohort in the past 10 years, this project intends to carry out structured and consistent (real world data)RWD processing, and conduct (real world evidence)RWE research related to perioperative safety and quality control in order to characterize the epidemiology of perioperative PSIs, explore the related factors, and construct a prediction model, and on the basis of which to construct a standardized platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a standardized platform for PSI reporting and analysis was constructed based on RWD.

NCT ID: NCT05891535 Recruiting - Clinical trials for Perioperative Complication

Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

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

Objective: To investigate perioperative and mid-term functional outcomes of stentless FloRIN reconfiguration as compared to standard technique performed with ureteral mono J placement. Patient and dataset Clinical and surgical data of all consecutive patients treated at our Institution from January 2021 to February 2022 with RARC, lymph node dissection (LND) and FloRIN reconfiguration were gathered in this single institution randomized 1:1 prospective series. All patients with clinical stage T1-T4N0-N1M0 amenable to radical cystectomy with curative intent and FloRIN reconfiguration were included. The sample size for a non-inferiority trial was calculated for different endpoints. Preoperative work-up included chest and abdomen contrast-enhanced computed tomography (CT) scan. Main exclusion criteria were: 1) presence of one or multiple tumor metastases at preoperative staging; 2) histopathological confirmation of bladder tumor at the level of prostatic urethra; 3) treatment without curative intent (cT4b, salvage or palliative cystectomies); 4) presence of urethral stricture. After preliminary multidisciplinary evaluation, patients were randomly assigned with 1:1 ratio to the mono-J stent placement or the stentless group. For the present study, only patients with a minimum 6 month-follow up were evaluated. Patient demographics, including ASA score and Charlson Comorbidity Index (CCI), peri- and postoperative features including operative time, conversion rate, estimated blood loss (EBL), Visual Analogue Scale (VAS) pain intensity scale, length of hospital stay (LOS) early (≤30 days) and delayed (>30 days) complications rate, and pathological data were thoroughly gathered. Follow-up schedule included blood analysis and CT scan performed three months after surgery, then every 6 months from the first to the third postoperative year, followed by annual imaging assessment according to individual risk profile, as postulated by the EAU guidelines. In case of newly diagnosed postoperative hydronephrosis, only patients with grade > 2 or symptomatic were assessed as functional failure. All eligible patients were offered the possibility to undergo neoadjuvant cisplatin-based chemotherapy before RARC. Patients with non-muscle invasive bladder cancer, cN+ disease and those presenting with severe cardiovascular morbidity or high preoperative creatinine levels, strongly contraindicating cisplatin administration, underwent immediate radical cystectomy. The enhanced recovery after surgery protocol (ERAS) was regularly applied. Suitable patients underwent a nutritional assessment with a specific immune-nutrition, 7 days preoperatively.

NCT ID: NCT05859620 Recruiting - Clinical trials for Myocardial Infarction

Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery

ImplementPMI
Start date: July 1, 2021
Phase:
Study type: Observational

The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients. Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.

NCT ID: NCT05738603 Recruiting - Clinical trials for Head and Neck Cancer

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.