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Trauma clinical trials

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NCT ID: NCT03894800 Completed - Trauma Clinical Trials

Determination of Analgesic Equipotent Doses of Inhaled Metoxyflurane vs. Intravenous Fentanyl

Start date: April 23, 2019
Phase: Phase 4
Study type: Interventional

The aim of this study is to determinate the equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.

NCT ID: NCT03868761 Completed - Anxiety Clinical Trials

Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In October, 2017, Northern California experienced devastating and historic wildfires. Sonoma Rises is an app designed for anyone who was impacted by this event and is intended to help survivors of disaster find their new normal. This study will assess the feasibility and efficacy of a self-help post-disaster mental health intervention delivered via a mobile app with a sample of teens who are experiencing post-disaster mental health symptoms.

NCT ID: NCT03867071 Completed - Trauma Clinical Trials

Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

EPREX
Start date: October 2005
Phase: N/A
Study type: Interventional

The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

NCT ID: NCT03861624 Completed - Trauma Clinical Trials

Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania

Start date: December 17, 2015
Phase: N/A
Study type: Interventional

The investigators propose to undertake a randomized, controlled trial which will generate Level 1 evidence concerning optimal fixation methods for the treatment of severe open tibia fractures in Dar es Salaam, Tanzania. The investigators hope to determine the optimal management of severe open tibial fractures in Sub-Saharan Africa in order to reduce long-term disability, limit the economic impact of injury, and avoid resource costs of reoperation. The investigators plan to compare the all-cause reoperation rate for AO/Orthopaedic Trauma Association (OTA) Type 42 open tibial shaft fractures treated with initial intramedullary nailing versus external fixation at Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, to compare rates of secondary clinical endpoints including postoperative superficial and deep infection, clinical union, radiographic union, malunion, and health-related quality of life with minimum one year follow-up, and identify prognostic factors related to the patient, injury, or management protocol that impact the reoperation rate, return to work, and health-related quality of life.

NCT ID: NCT03846115 Completed - PTSD Clinical Trials

A Mobile App for Peer-led Seeking Safety

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

Peer support is historically prominent for substance use disorder (SUD), such as the world-wide model of Alcoholics Anonymous and other 12-step groups. Yet for trauma and posttraumatic stress disorder (PTSD) there have been few attempts at peer help. A major challenge of trauma peer groups is that they usually focus on telling the story of members' trauma histories, which can be overly triggering and distressing. Seeking Safety offers an excellent choice for peer-led care. It is an evidence-based and is the most widely adopted model for SUD/PTD. It is present-focused, cognitive-behavioral, and provides psychoeducation and coping skills to help clients attain greater safety in their lives. It has been successfully implemented in peer-led format for many years and has been studied in various trials, including a recent randomized controlled trial (RCT) comparing peer versus professional delivery, with positive results. In Phase 1 we developed a beta version of a mobile app for peer-led Seeking Safety (PLSS). In Phase 2 we will enhance the app features and content and also conduct an RCT in a sample of adults with current SUD/PTSD to compare the Peer Safety app condition to a control app.

NCT ID: NCT03846024 Terminated - Trauma Clinical Trials

Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function

RibFx
Start date: July 25, 2018
Phase: N/A
Study type: Interventional

Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant treatments to improve rib fracture pain and outcomes. Prior studies have evaluated outcome measures for traumatic rib fractures that include respiratory failure, tracheostomy requirement, ICU length of stay, hospital length of stay, narcotic requirement, daily maximum incentive spirometry volume, pneumonia, and mortality . Rib belts, which have been present since at least 1945, have long been used to provide pain relief via chest wall stabilization [3]. However there is an extreme paucity of literature regarding their clinical efficacy, and their use has largely been abandoned due to concerns that they may have been overly constricting and resulted in poorer respiratory (pulmonary/breathing) outcomes. Newer generation rib belts are more elastic and theoretically less constricting than their earlier generation predecessors, however their clinical efficacy has not been yet demonstrated. The investigators will therefore plan to perform a prospective trial to determine if these rib strapping devices are effective clinical tools in the traumatic rib fracture population. The goal of the study is institutional quality improvement, to determine if the investigators see benefit of these devices for the pain management of our trauma population. The investigators will also conduct this as a pilot trial for hopeful future research applications, however the overall goal is institutional improvement. Patients determined to be eligible for the study by the admitting physician (and per the previously defined criteria) will be recruited to enroll in the project within the first 24 hours of their hospital admission. Recruited patients will be offered the opportunity to consent to enrollment in the study and will be assigned by the study team into either the intervention (RibFx belt +current standard of care) or control (current standard of care) arm in a quasi-experimental prospective design: untreated control group with dependent pretest and posttest samples. In this manner, the intervention arm will be both compared to themselves (pretest vs. posttests) as well as to a control group not exposed to the intervention. The relevant study materials will be included in their paper (physical) and electronic chart. Patients upon enrollment in the study will undergo an initial assessment that will include their baseline pain scores, narcotic consumption, incentive spirometry scores, and the subjective self-reported results of their questionnaire (the pre-test questionnaire- see attached). Patients will continue to be scored on objective (incentive spirometry results, opioid pain medicine consumption) and subjective variables (pain scores) during their hospital course. Between 24-48 hours after enrollment, they will be prompted to again complete a similar 2nd questionnaire post-test (if they are discharged from the hospital at this point in the time course, they will be sent home with the questionnaire and prompted to complete it at home). At their follow up appointment in trauma clinic (which will be coordinated by the research team to be as close as possible to 3 weeks post injury), they will have the opportunity to again voluntarily complete a final short questionnaires (post-test) that assess their pain control and respiratory function over the last 3 weeks. At this point, their involvement in the trial will be complete. Patients themselves will play an active role in data collection during the trial, and will be instructed and prompted in how to do so. Patients will be expected to fill out a worksheet on a daily basis, both while inpatient and after discharge, on their daily incentive spirometry scores as well as their minimum and maximum pain scale scores. This will be used to supplement the survey or questionnaire data, as well as the objective data from the electronic medical record. The investigators will ultimately compare groups using a quasi-experimental design as follows: Untreated control group with dependent pretest and posttest samples. This will allow for a direct comparison of patient to patient within the intervention arm (patient pretest result serving as control compared to posttest result) . To observe for temporal variability, their will be a control group with no intervention as well (no rib belt worn) , however the principle aim of the study is the comparison of patients to themselves in a pre-test, post-test fashion.

NCT ID: NCT03842553 Completed - PTSD Clinical Trials

Posttraumatic Stress Symptoms Among Rescuers at Risk

Start date: June 2014
Phase:
Study type: Observational

This cross-sectional, anonymous online survey aims to examine how salient variables influence PTSS, well-being, and suicidal ideation across the following professions of rescue workers: firefighters, ambulance personnel, police officers, and emergency and psychiatric nurses. PTSS, coping strategies, well-being, suicidal ideation, previously experienced and work-related trauma, and self-efficacy were measured and analyzed using multiple regression and structural equation modeling.

NCT ID: NCT03840798 Completed - Trauma Clinical Trials

Disseminating Child Abuse Clinical Decision Support to Improve Detection, Evaluation and Reporting

Start date: March 26, 2019
Phase:
Study type: Observational

Child maltreatment is a leading cause of death and disability in children. More than 3 million reports to Child Protective Services are made every year in the US and almost 1,600 children die annually due to maltreatment. Children who are victims of maltreatment often have significant lifelong adverse health, social, and economic consequences. Accurate and timely recognition of the early signs of child maltreatment is critical to decreasing morbidity and mortality. A significant proportion of children who suffer severe morbidity and/or mortality from maltreatment had been previously evaluated by physician(s) who did not recognize the abuse. The American Academy of Pediatrics has evidence-based recommendations for the testing which should be done as part of the medical evaluation of children with suspected physical abuse. However, despite these evidence-based recommendations, physicians fail to consistently screen for and evaluate for abuse even in high-risk situations. The investigators have developed and evaluated what the investigators believe to be the first, comprehensive electronic health record (EHR) based child abuse clinical decision support (CA-CDS). This EHR-based CA-CDS system informs medical care at multiple points during the care for a potentially maltreated child, beginning with identification of suspected abuse to the handing off of information to CPS which has a mandate to protect children who are victims of suspected maltreatment. The investigators are disseminating the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system which they developed as part of the investigator's initial PCORI grant. 1. a universal child abuse screen (CAS) - supports identification of maltreatment 2. an embedded child abuse alert system - supports identification of maltreatment 3. alerts to physicians and advanced practice providers - supports identification of maltreatment 4. physical abuse order set - supports proper evaluation of suspected physical abuse 5. documentation assistance for making reports of suspected maltreatment to Child Protective Services - supports mandated reporting The primary objective is to disseminate and implement CA-CDS in two different EHRs in two hospital systems - Northwell Health (NY) and University of Wisconsin (WI) - and to assess whether the CA-CDS improves identification, evaluation and mandated reporting of child maltreatment. Aim #1 is to compare the rates of identification of possible child abuse - defined as reports to Child Protective Services - before and after integration of CA-CDS into the EHR among children presenting to 5 Emergency Departments in two different health systems. Aim #2 is to compare the rate of physician compliance with American Academy of Pediatrics guidelines for evaluation of suspected physical abuse before and after integration of CA-CDS into the EHR in 5 Emergency Departments in two health care systems. Once the D&I is complete, the investigators will have demonstrated the feasibility of implementing the CA-CDS in the three EHRs which make up 85% of all the US EHRs. This is a critical step towards the goal of having a CA-CDS as a standard EHR component.

NCT ID: NCT03839914 Recruiting - Trauma Clinical Trials

Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

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

Surgical site infections (SSI) are not uncommon, especially in specific high-risk groups including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized measures have been adopted to reduce surgical site infection, and the use of topical vancomycin powder has gained popularity in recent years. Given the lack of high-quality evidence for the use of topical vancomycin to reduce surgical site infections in open posterior spine surgery, which is currently the most common approach to spine surgery, it is crucial to study the use of vancomycin powder in reducing surgical site infections. This study is a prospective, single-blinded open label randomized controlled trial, with one arm of patients having local administration of 1g vancomycin powder which will be placed in the deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic surgeon, whereas the control arm will be without such application of vancomycin. Both arms of patients will still be undergoing the same operation procedures, as well as postoperative local wound drainage and wound care. This study will provide insights on the reduction rate in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of using topical vancomycin in reducing surgical site infection between different disease groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These proposed findings will provide valuable information for clinicians and institutions on future measures for surgical site infection of open posterior spine surgery.

NCT ID: NCT03831412 Completed - Insomnia Clinical Trials

Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy

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

The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.