View clinical trials related to Pressure Injury.
Filter by: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.
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.
The primary goal of this study is to explore whether applying the Mepilex foam on the nasal bridge directly between the skin and the N95 mask will prevent nasal bridge pressure injury among nursing staff, secondary to long-term ( >8+ hours) wear time. The secondary goal is to evaluate if using the Mepilex maintains the seal of the mask.
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.
This study was planned as a prospective randomized controlled clinical trial to determine the effect of evidence-based skin care interventions and hydrocolloid dressings in preventing nasogastric induced pressure injuries in critically ill patients.
Our primary objective is to understand the impact of our quality improvement objectives on pressure injury and wound care outcomes. We will follow patients admitted to our facility who receive the standard of care for a up to a year. Patients to be followed will fall into one of four groups: acute wounds, chronic wounds, pressure injuries present at time of admission and at risk for pressure injuries.
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.
Nasal Continuous Positive Airway Pressure (NCPAP) is a respiratory support for neonates with Respiratory Distress Syndrome (RDS) and represents the gold standard for RDS treatment in many Neonatal Intensive Care Units (NICU). Respiratory supports providing Synchronized Nasal Intermittent Positive Pressure Ventilation may further enhance the success of non-invasive respiratory support. The most significant risk factor associated to NCPAP management is nasal trauma. Nasal injuries represent a source of pain and discomfort for infants. In some cases, they could become a site of infection and cause functional, cosmetic, long term outcomes as erythema or necrosis of the columella nasi. The aim of this study is to evaluate the effectiveness of nursing interventions to reduce the incidence of pressure injuries during NCPAP support in infants admitted to NICU. It is hypothesized that implementation of some preventive interventions could improve nursing care quality and reduce nasal pressure injuries.
A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.