Active clinical trials for "Barotrauma"

Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.

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.

Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. One study related to recreational diving reports that ENT barotrauma concern 10% of dives with experimented divers and 30% with novice divers. Nevertheless, a low number of studies were realized on ENT barotrauma, particularly those involving middle ear and sinuses, maybe because most of them evolve favorably without sequelae. Besides, it has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But once again no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence. Few data on military population exist either. However, operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Furthermore, therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption. The purpose of this research is to study middle ear and sinus barotrauma thanks to questionnaires focused on those pathologies and their potential risk factors. The hypothesis is that it will allow identification of main risk factors in order to develop preventive measures as well as the characteristics and missions of concerned divers and the impact of those barotrauma on this population.

Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.

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.

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.

Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are the most commonly used. A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%) NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported to improve patient - ventilator synchrony and minimize mean airway pressure and ability to wean an infant from a ventilator. However till date there has been no head to head comparison of extubation failure in infants managed on NAVA with conventional ventilator strategies. In this study the investigators aim to compare primary extubation failure rates in infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA ventilator settings and will be assessed for primary extubation failure (defined as reintubation within 5 days after an elective extubation).

A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).

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

Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. The investigators randomly assigned patient-treatment group exposures to four different time interval and rate (slope) of compression. These total time intervals of compression and rates (slopes) of compression are identical to those used in the Phase I trial. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the 4 compression schedules, similar to ther Phase I trial will be recorded. Patients who are symptomatic and require compression stops (as in the Phase I trial) using a United States Navy Treatment Table 9 (USN-TTN9) during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be analyzed. Analysis using descriptive and inferential statistics will be applied to the patients requiring first stops in the 4 compression profiles. This Phase II study increases the sample size of treatments and they will be combined with the total number of treatments used in the original phase I study. This will increase power to facilitate detailed descriptive analysis and to determine if the findings are robust in the phase I study.