Clinical Research Directory

Health, Fitness, and Safety Knowledge as Determinants of Adverse Events in Recreational Divers in Poland

This cross-sectional online survey study assesses health status, physical fitness, and safety knowledge as potential determinants of diving-related adverse events among recreational divers in Poland. Recreational diving exposes participants to specific hazards, including decompression sickness (DCS) and barotrauma of the middle ear, sinuses, and lungs. To date, no Polish study has simultaneously evaluated health, physical fitness, theoretical safety knowledge, and the occurrence of adverse events in this population. Adult divers (18 years or older) who completed at least one dive in the past 24 months and reside in Poland complete an anonymous online questionnaire (about 12 to 18 minutes). Physical fitness is estimated as VO2max using the University of Houston Non-Exercise Test (physical activity rating, age, BMI, and sex). Knowledge of DCS, barotrauma, and safe-diving rules is tested at three difficulty levels. The questionnaire also captures diving exposure, certification level, chronic health conditions, and risky behaviours (smoking, alcohol use, and diving beyond certification). The primary endpoint is the proportion of divers reporting at least one diving-related adverse event. Associations with certification level, estimated VO2max, BMI, and other factors are analysed using multivariable logistic regression. The study is non-interventional, anonymous, and carries minimal risk; no clinical procedures or biological sampling are involved.

Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System

This validation study investigates the diagnostic precision and accuracy when grading otic barotrauma using two alternative gradings systems including the TEED and the OGS grading systems. Background There are two grading systems used to grade otic barotrauma. They include the Teed Score (TEED) and the O'Neill Grading System (OGS). Teed has been utilized more extensively but among physicians has been found to have limitations. The OGS is an alternative grading system with less classification categories than what the Teed classification system utilizes. The OGS system is tied directly to treatment decision making, specific to the respective grading level. Methods This study will utilize a sample of clinical examiners who will independently grade 120 digital color photos of actual patient tympanic membranes with and without evidence of eustachian tube dysfunction and middle ear barotrauma including variable stages or grades of otic barotrauma. They will use the TEED chart as a reference in selecting the appropriate TEED score for each of the photos. Simultaneously they will also utilize the OGS chart as a reference in selecting the appropriate OGS grade for each of the photos. The grading will be conducted by physicians, nurses, and technicians. This will allow for comparisons at varying provider levels. The comparisons will be made using the kappa statistics across the disciplines. This will allow comparison between observed agreement, and expected agreement due to chance for all reviewers. Research Hypothesis Ho: There is no difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems. Ha: There is a difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems.

Barotrauma in Hyperbaric Oxygen Therapy

The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.

Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)

Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition . Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty

Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS

The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate \>60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19/non-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.