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Abdominal Injuries clinical trials

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NCT ID: NCT06182488 Recruiting - Acute Abdomen Clinical Trials

Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy

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

The goal of this clinical trial is to test the safety and effectiveness of the ERAS protocols compared to a conventional care protocols in patients who received emergency laparotomy. The main question it aims to answer are: • Can the ERAS protocols be used safely and effectively in patients undergoing emergency laparotomy? Participants will be randomised into the ERAS group and the conventional group and will be given the ERAS protocols and the conventional protocols in the perioperative period. Researchers will compare the ERAS group with the conventional group to see if the ERAS programme is effective.

NCT ID: NCT05910567 Recruiting - Wounds and Injuries Clinical Trials

A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma

FAST
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

Bleeding from intra-abdominal injuries is a leading cause of traumatic deaths in children. Abdominal CT is the reference standard test for diagnosing intra-abdominal injuries. Compelling reasons exist, however, to both aggressively evaluate injured children for intra-abdominal injuries with CT and to limit abdominal CT evaluation to solely those at non-negligible risk. The focused assessment sonography for trauma (FAST) examination can help focus patient evaluation in just this manner by potentially safely decreasing abdominal CT use in low risk children. This research study is a multicenter, randomized, controlled trial to determine whether use of the FAST examination, a bedside abdominal ultrasound, impacts care in 3,194 hemodynamically stable children with blunt abdominal trauma. The overall objectives of this proposal are 1) to determine the efficacy of using the FAST examination during the initial evaluation of children with blunt abdominal trauma, and 2) to identify factors associated with abdominal CT use in children considered very low risk for IAI after a negative FAST examination. The long-term objective of the research is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality.

NCT ID: NCT05627908 Recruiting - Abdominal Trauma Clinical Trials

The PseAn Study - Study Protocol

PseAn
Start date: October 1, 2022
Phase:
Study type: Observational

The researchers aim to study the role of contrast ultrasound in detecting post-traumatic splenic, hepatic, and renal PAs compared with the gold standard of CT with intravenous contrast at different follow-up time points, and whether it can replace CT scan in the follow-up of solid organ injuries

NCT ID: NCT05288985 Recruiting - Trauma Abdomen Clinical Trials

Impact of Loco-regional Analgesia Following Placement of Erector Spinae Plane Catheter in Addition to Systemic Analgesia in Patients With Thoracic Trauma

ERECTRAUTHO
Start date: July 29, 2022
Phase: N/A
Study type: Interventional

The management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications. A multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. It must combine effectiveness and simplicity with the least risk to the patient. Today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications. The investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma. The aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. The interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.

NCT ID: NCT05171296 Recruiting - Intensive Care Unit Clinical Trials

Noninvasive Hemoglobin Monitoring by Spectrophotometry in Blunt Abdominal Trauma Patients for Conservative Management

Start date: November 22, 2021
Phase:
Study type: Observational

We aimed to study the efficacy of Noninvasive Hemoglobin Monitoring by Spectrophotometry in monitoring hemoglobin level in trauma patients for conservative management.

NCT ID: NCT05127109 Recruiting - Surgery Clinical Trials

The PASTDUe Nutrition Ecosystem Project (PASTDUe)

PASTDUe
Start date: April 25, 2022
Phase: Phase 4
Study type: Interventional

This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.

NCT ID: NCT04937868 Recruiting - Aortic Dissection Clinical Trials

Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

NEXUS AP CT
Start date: January 15, 2018
Phase:
Study type: Observational

Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.

NCT ID: NCT04718441 Recruiting - Abdominal Injury Clinical Trials

Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

Start date: May 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.

NCT ID: NCT03815370 Recruiting - Peritonitis Clinical Trials

A Non-Traumatic Binder for Temporary Abdominal Wall Closure

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

At the end of most abdominal operations, the fascial layer is closed by stitching edges of the wound together. However, because of logistic and/or technical reasons or the patient's critical condition, the surgeon is forced to leave the abdomen open. The current approach for temporary coverage of abdomen is vacuum assisted techniques (VAT). This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site. Although this is the most successful and commonly used procedure, there are some limitations to this method. For example, VAT have little effect on preventing lateral movement of the wound edges. Therefore, VAT it is not the ideal procedure in aiding surgeons to closed the abdomen. The purpose of this study is to compare usual care (vacuum or non-vacuum methods for temporary coverage of the OA) versus usual care plus a novel new abdominal binder device called ABRO™ that may aid in the closure of patients who undergo open abdomen closure procedures.

NCT ID: NCT03490929 Recruiting - Trauma Abdomen Clinical Trials

CEUS for Blunt Abdominal Trauma in Children

Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.