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Surgery clinical trials

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NCT ID: NCT05418517 Not yet recruiting - Surgery Clinical Trials

Hospital Acquired Pneumonia in Temporary Tracheostomy

HAP
Start date: June 2022
Phase:
Study type: Observational

Medical condition or disease under investigation: Oromaxillofacial surgery in head and neck cancer Purpose of research: Retrospective data analysis identifying hospital acquired pneumonia in patients who undergo temporary tracheostomy with oromaxillofacial surgery and free flap reconstruction Primary objective: Undertake an adequately powered, robustly designed observational cohort study that describes the rates of hospital acquired pneumonia in patients who undergo a tracheostomy and those that undergo overnight intubation during oromaxillofacial surgery for HNC. Secondary objective: To investigate whether smoking history, respiratory history (COPD, asthma) or size of tumour are associated with an increased risk of developing hospital acquired pneumonia. Number of Subjects/Patients: 193 Study Type: Observational cohort Main Inclusion Criteria: Patients who underwent oromaxillofacial resection with free flap reconstruction and tracheostomy from 1st January 2018 to 31st December 2018. Patients who underwent oromaxillofacial resection with free flap reconstruction and with overnight intubation from 1st January 2014 to 31st December 2014 Statistical Methodology and Analysis: A power calculation has been used to determine the sample size required for statistical analysis of data. Statistical significance for rates of HAP will be tested between the two groups.

NCT ID: NCT05416944 Active, not recruiting - Surgery Clinical Trials

Perioperative Personalized Blood Pressure Management: IMPROVE-multi

IMPROVE
Start date: February 26, 2023
Phase: N/A
Study type: Interventional

Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.

NCT ID: NCT05416047 Recruiting - Surgery Clinical Trials

An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy

Start date: May 30, 2022
Phase:
Study type: Observational

Over 30,000 emergency abdominal operations (laparotomy, EmLAP) are performed in the UK annually and they are usually performed in adults over the age of 65. As such, it can be a risky operation with high chance of developing complications, including death, especially if there is frailty before the operation. Such patients are much more susceptible to infections or to have complications, such as wound breakdown, because of poor healing. Whilst some patients might be frail from the outset, surgery can cause patients to become frail ('surgical frailty'). This can happen in all age groups, not just the elderly and is not uncommon after an EmLap. This study aims to establish blood tests (biomarkers) associated with frailty, explore the ability of frailty markers measured before EmLAP to predict death after EmLAP, define changes in frailty in EmLAP patients and analyse the influence of frailty on quality of life post EmLAP. Over 2 years, 150 patients age ≥40 undergoing EmLAP in a hospital will be recruited and followed up for 90 days looking at different frailty markers. These include (a)blood tests (biomarkers) analysed in a special laboratory machine called mass spectrometer to identify chemical markers linked to frailty status (b)CT scan looking at muscle bulk (sarcopenia) (c)Rockwood Clinical Frailty Score, a scoring system assessing how much a patient can do (1 is fit; 9 is extremely frail). The investigators hope that these results will improve our understanding of frailty and lead to further research to improve outcomes for EmLAP patients.

NCT ID: NCT05396703 Completed - Surgery Clinical Trials

TOETVA Feasibility and Complications - Single Center First Experience

Start date: October 22, 2019
Phase:
Study type: Observational

All participants who underwent (or will undergo) a transoral endoscopic thyroidectomy via vestibular approach (TOETVA) at the investigators' center are observed for complications and feasibility of this surgery. Anonymised data relevant to the participants' condition will be used.

NCT ID: NCT05389852 Completed - Surgery Clinical Trials

Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

TwoDex
Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.

NCT ID: NCT05388383 Not yet recruiting - Surgery Clinical Trials

Cost-effectiveness Analysis of Robot-assisted Spinal Surgery

Start date: June 1, 2022
Phase:
Study type: Observational

With the change of lifestyle and the aging of the population, the prevalence of Lumbar disc herniation (LDH) in my country is increasing year by year, and surgery is one of the main ways to treat LDH. Surgical robots have good application prospects in the surgical treatment of patients with lumbar degenerative diseases. Studies have shown that orthopedic robot-assisted surgery has less soft tissue damage, small surgical incisions, less bleeding, high safety, and quick postoperative recovery; it reduces the risk of spinal cord and blood vessel damage that may be caused during manual operations; does not require repeated fluoroscopy To determine the position of the nail, reduce the intraoperative radiation by more than 70%, and reduce the risk of patient infection. The current clinical research on robotics technology mainly stays in the aspects of accuracy, effectiveness, and safety. If the technology is promoted in clinical applications, the support of health economics evaluation data is urgently needed. This study hopes to apply robot-assisted technology in LDH surgical treatment through observational research design, evaluate the therapeutic effect and treatment cost of robot-assisted surgery and conventional surgery, focus on health economics evaluation, and provide treatment options for patients and medical care in the health sector. The reasonable allocation of resources and the promotion and application of this technology provide data support.

NCT ID: NCT05386940 Completed - Surgery Clinical Trials

Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery

Start date: July 22, 2019
Phase:
Study type: Observational [Patient Registry]

Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.

NCT ID: NCT05386901 Enrolling by invitation - Surgery Clinical Trials

The Effects of Individualized Lung-protective Ventilation With Lung Dynamic Compliance-guided Positive End-expiratory Pressure(PEEP) Titration on Postoperative Pulmonary Complications of Pediatric Video-assisted Thoracoscopic Surgery

PEEP
Start date: June 10, 2022
Phase: N/A
Study type: Interventional

This study evaluates the influence of individualized lung-protective ventilation strategy(LPVS) on postoperative pulmonary complications(PPCs) through a randomized controlled trial when children undergoing thoracoscopic surgery with one-lung ventilation(OLV).The investigators evaluate the impact of using lung dynamic compliance-guided Positive End-expiratory Pressure(PEEP) versus conventional PEEP on a pressure-controlled ventilation(PCV).The researchers also analyzed perioperative vital signs and respiratory indicators of these LPVS.

NCT ID: NCT05377554 Recruiting - Surgery Clinical Trials

ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488.

NCT ID: NCT05375669 Recruiting - Surgery Clinical Trials

The Effect of Increasing Current or Pulse Duration on Patient Movement and Intraoperative Transcranial Electric Stimulation Motor Evoked Potential Amplitude

CCCV
Start date: August 10, 2022
Phase: N/A
Study type: Interventional

Transcranial electric stimulation (TES) motor evoked potential (MEP) monitoring is standard during surgery risking motor system injury. The stimuli are typically 5-pulse trains with a 4 ms interstimulus interval (ISI). The pulse duration (D) is often set to 50 or 500 µs. Both are effective, but setting D to the chronaxie would be physiologically optimal and limited data suggest that mean MEP chronaxie may be near 200 µs. When necessary, one can obtain larger MEPs by increasing current (I) or D to increase stimulus charge (Q = I × D). However, this also increases patient movement that can interfere with surgery and reduce MEP acquisition frequency. The main research question is whether increasing current or pulse duration when applying intraoperative neuromonitoring produces less patient movement during surgery. As such, the IOM ISIS System will be employed for neuromonitoring and an accelerometer will be used to quantify patient movement. The constant-current TES stimulators will be used in this study with a high-precision oscilloscope. Total intravenous anesthesia (TIVA), surgery and TES MEP monitoring will proceed routinely without modification and normally involves acquiring many MEPs over several hours. The only departure from standard care will be the placement of two small accelerometers and a brief MEP sequence before skin incision to determine chronaxie and compare the effect of an equivalent increase of I or D on MEP amplitude and movement.