Clinical Research Directory

Optimized Costoclavicular Block for Elderly Proximal Humeral Fracture Surgery

Background: Proximal humeral fractures are common in elderly patients and often require surgical fixation (open reduction and internal fixation). Traditional regional anesthesia techniques, such as the interscalene brachial plexus block, may provide incomplete pain relief in the medial upper arm area and carry a high risk of hemidiaphragmatic paralysis, which can lead to breathing difficulties. Objective: This study aims to evaluate whether an optimized nerve block strategy-ultrasound-guided costoclavicular brachial plexus block combined with superficial cervical plexus block and T2 thoracic paravertebral block-improves anesthetic success and reduces diaphragm dysfunction compared to the traditional interscalene approach in elderly patients undergoing proximal humeral fracture surgery. Study Design: This is a multicenter, prospective, randomized, controlled, double-blind (participants and outcome assessors), superiority clinical trial. Population: A total of 356 elderly patients (aged ≥65 years) with unilateral proximal humeral fractures scheduled for open reduction and internal fixation via an anterior surgical approach will be enrolled from three centers in Shanghai, China. Intervention: Participants will be randomly assigned in a 1:1 ratio to one of two groups: * Experimental Group (Optimized Strategy): Receives ultrasound-guided costoclavicular brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (0.375% ropivacaine 20 mL for brachial plexus, 0.25% ropivacaine 10 mL for each of the other blocks). * Control Group (Traditional Strategy): Receives ultrasound-guided interscalene brachial plexus block + superficial cervical plexus block + T2 thoracic paravertebral block (same drug regimen). All nerve blocks will be performed under ultrasound guidance by a single anesthesiologist. Patients and outcome assessors will be blinded to group assignment; the performing anesthesiologist cannot be blinded due to the distinct anatomical approaches. Main Outcomes: * Primary Outcome: Nerve block success rate, defined as no pain or only mild pain requiring no rescue analgesics (e.g., intravenous opioids, conversion to general anesthesia, or local infiltration) during surgery. * Key Secondary Outcomes: Rate of hemidiaphragmatic paralysis (assessed by ultrasound M-mode); rate of conversion to general anesthesia; postoperative pain (NRS, 0-10) at 24 hours; perioperative stress biomarkers (cortisol, ACTH, IL-6, HMGB-1, CRP, galectin-3); and postoperative shoulder function recovery. Safety Monitoring: Adverse events, including unplanned conversion to general anesthesia, respiratory depression, pneumothorax, and severe hemidiaphragmatic paralysis, will be recorded and managed according to predefined protocols. An independent Data Monitoring Committee will review safety data and conduct interim analyses for futility. Study Duration: The study is expected to take approximately 24 months from first patient enrollment to final follow-up completion. Ethical Approval: This study has been approved by the Ethics Committee of Shanghai Tongren Hospital. Approvals from the ethics committees of the other participating centers (Shanghai Sixth People's Hospital and Shanghai Xuhui Central Hospital) will be obtained before study initiation at those sites.

Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU

Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.

Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis

Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity. Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation. While its benefits have been reported in retrospective reports, prospective studies are lacking. This prospective observational cohort study aimsto evaluate the short- and long-term effects of robot-assisted diaphragmatic plication on subjective breathlessness, physical performance, lung function, blood gases, and imaging findings at five Swedish university hospitals: Gothenburg, Linköping, Lund, Umeå, and Uppsala. Patients will be assessed preoperatively and postoperatively after one to three months and after one and three years.

A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis

A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.

Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis: Patient Experiences and Reported Outcomes.

This study utilizes a grounded theory methodology to explore patient experiences of phrenic nerve reconstructive surgery as a treatment for diaphragmatic paralysis.