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Surgery clinical trials

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NCT ID: NCT03141411 Completed - Surgery Clinical Trials

Assisted Fluid Management vs Manual GDFT

Start date: May 10, 2017
Phase: N/A
Study type: Observational

Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

NCT ID: NCT03141190 Completed - Surgery Clinical Trials

Mindful Mental Training for Surgeons to Enhance Resilience and Performance Under Stress

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Background: Burnout and overwhelming stress are growing issues among surgeons and are associated with mental illness, attrition and diminished patient care. Among surgical trainees, burnout and distress are alarmingly prevalent but high inherent mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout and overwhelming stress by more than 75%. In other high-stress populations formal mindfulness training has been shown to improve mental health and buffer overwhelming stress and yet this approach has not been tried in surgery. The aim of this study is to evaluate feasibility and acceptability of modified mindfulness-based stress reduction (MBSR) training among PGY-1 surgery residents and to obtain initial evidence of efficacy in regard to well-being and performance. Design: A pilot randomized clinical trial of modified MBSR versus an active control. Setting: Residency training program, tertiary academic medical center. Participants: PGY-1 surgery residents. Intervention: Weekly two-hour modified MBSR classes (compared to an active control) and 20 minutes of suggested daily home practice over an eight-week period. Main Outcomes and Measures: Primary outcome is feasibility, assessed along six domains (demand, implementation, practicality, acceptability, adaptation and integration), using focus groups, interviews, surveys, attendance, daily practice time and subjective self-report of experience. Secondary outcomes include perceived stress, mindfulness and executive function (specifically working memory capacity), followed by psychosocial well-being (burnout, depression, resilience), performance (motor skills testing) and functional brain scans focused on areas associated with reappraisal as a surrogate for emotional control. This study seeks to demonstrate the feasibility of mindfulness training in surgery PGY-1s while simultaneously providing preliminary quantitative data on the effects of mindfulness training in a randomized, controlled setting. Data will inform modifications to the MBSR curriculum that enhance feasibility and inform sample size calculations for subsequent, adequately-powered RCTs which will likely need to be multi-center trials. Results could potentially impact formal medical training, the mental health of providers at every level, and the overall quality of patient care.

NCT ID: NCT03137901 Completed - Surgery Clinical Trials

Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring

Capstesia
Start date: May 10, 2017
Phase:
Study type: Observational

This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO monitoring ( EV-1000, Edwards Lefesciences, USA)

NCT ID: NCT03135080 Completed - Surgery Clinical Trials

The Effect of Long-Term HEAD START Training on Surgical Skill Levels

Start date: May 17, 2017
Phase: N/A
Study type: Interventional

The research group developed a surgical simulation device, the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. In most settings, HEAD START is utilized once during training, then surgeons move on to live surgery and typically do not return to the simulator. The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training, since many surgeons operate seasonally, with long periods of downtime between surgical camps and with little field supervision. Participating surgeons will practice on HEAD START weekly, with monthly feedback from a senior supervisor. Researchers will assess their skill level at the start of HEAD START training and again at the start of the new surgical season in the fall of 2017. Researchers will also administer questionnaires to elicit feedback on the HEAD START training and supervision process.

NCT ID: NCT03128827 Completed - Surgery Clinical Trials

Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol

Start date: August 4, 2011
Phase: N/A
Study type: Interventional

The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).

NCT ID: NCT03124901 Completed - Healthy Clinical Trials

Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor

Start date: September 30, 2008
Phase: N/A
Study type: Interventional

In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

NCT ID: NCT03124693 Completed - Healthy Clinical Trials

Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor

Start date: August 12, 2008
Phase: N/A
Study type: Interventional

In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

NCT ID: NCT03123354 Completed - Surgery Clinical Trials

Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

Start date: May 1, 2015
Phase: N/A
Study type: Interventional

The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.

NCT ID: NCT03117790 Completed - Surgery Clinical Trials

Impact of Dexmedetomidine on Sleep Quality

Start date: June 26, 2017
Phase: Phase 4
Study type: Interventional

Sleep disturbances frequently occur in elderly patients after major surgery; and their occurrence are associated with worse outcomes including increased incidence of delirium. Previous studies showed that, for elderly patients admitted to the ICU after non-cardiac surgery, low-dose dexmedetomidine infusion improved to some degree the quality of sleep and reduced the incidence of delirium. The investigators hypothesize that, for elderly patients after major non-cardiac surgery, dexmedetomidine supplemented analgesia can also improve the sleep quality. The purpose of this randomized controlled pilot study is to investigate the impact of dexmedetomidine supplemented analgesia on the sleep quality in elderly patients after major non-cardiac surgery.

NCT ID: NCT03116997 Completed - Surgery Clinical Trials

Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

Start date: April 7, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.