View clinical trials related to Crush Injuries.
Filter by:When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasotracheal and orotracheal intubation.
This study describes a procedure to collect a subject's position, movement, physiological data and usability information using Masimo's investigational device.
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
The presence of pressure injuries has been considered a quality indicator of health care services and efforts has been made to develop guidelines to prevent this issue. Intensive care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due to reduced mobility of critically ill patients and large number of devices and hard technologies that jeopardize preventive measures, such as, decubitus changes. There are not current definitive evidence about the superiority of any support surface to treat or prevent pressure injuries. The objective of the present study is to analyze if the use of viscoelastic support surface in vulnerable critically ill patients decreases the incidence of pressure injury compared with pyramidal foam support surface. Randomized clinical trial performed in an intensive care unit for adult patients in a philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤ 14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay, contraindication of performing complete institutional preventive measures for support injuries, presence of support injuries at ICU admission or absence of informed consent. Randomization will be made by computerized generated numbers and patients will be allocated in two groups in a ratio of 1:1. All study patients will be cared for according to standard institutional preventive measures. The interventional group will be placed in an ICU bed with viscoelastic support surface and the control group in an ICU bed with pyramidal foam support surface. The main outcome evaluated will be the occurrence of type II pressure injury. Secondary outcomes are the time to the occurrence of pressure injury, length of ICU and hospital stay and 28 days mortality rate. Significance level will be 5%.
The goal of the project is to study whether multidisciplinary follow- up performed via telemedicine to the patient in his or her own home, will improve the healthcare services offered to a particular group of patients. The hypotheses are that this could increase the treatment options, increase knowledge translation, give significant socioeconomic benefits, and allow greater accessibility to specialized healthcare services, as well as increase the involvement of patients and those working in primary healthcare.
Dolutegravir is an HIV-1 integrase inhibitor which is marketed as a single tablet (Tivicay®) and in a fixed dose combination tablet with abacavir and lamivudine (Triumeq®, referred to as TRI). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. Currently there is no information about crushing TRI tablets. Therefore this study will be conducted to investigate whether crushed and suspended TRI and crushed and suspended TRI with drip feed are bioequivalent to taking TRI as a whole.
The first aim of the study is to prove that after starting the therapy with crushed tablets, the platelet inhibition will be as expected after starting therapy with intact tablets. Gurbel et al. showed that 100% of the patients on ticagrelor treatment have a decrease from baseline platelet aggregation of >10% 4 hours after last maintenance dose. So the investigators expect that after 3 days of treatment, all of our patients will have a closing time of more than 106seconds. The investigators will observe two different clinical conditions of Acute Coronary Syndrome. First after semi-urgent coronary artery bypass graft (CABG) surgery, secondly in patients after cardiac arrest. Both are clinical situations in which crushed tablets are needed to give. The second objective is to determine plasma concentrations of Ticagrelor and AR-C124910XX (active metabolite of ticagrelor) in these two patient populations after receiving 180mg or 90mg start-dose. Determination of plasma concentrations is done after protein precipitation, by using liquid chromatography with mass spectrometry detection. Measurements will be determined before intake (0h) and at 0,5; 1; 2; 4; 8; 24h and at day 4 +4h.7 The first 24h this will be a crushed tablet and 4 hours after the first intake at day 4 of therapy, this will be a non crushed tablet.
Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination tablet with cobicistat, tenofovir and emtricitabine (Stribild®, referred to as STB). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. In addition if HIV patients develop opportunistic infections, patients can become severely ill and may end up on the intensive care. Patients at the intensive care might not be able to swallow medication. Therefore it is useful to know if it is possible to administer STB through a different route, like a feeding tube. If STB can be crushed or dissolved and given through a catheter it is also useful to know if it can be given with drip feed. Currently there is no information about crushing STB tablets. "Crushing STB tablets into a liquid medium has not been studied and is not recommended" according to the SPC text. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. It is important to know whether pharmacokinetics are influenced by crushing of tablets as low concentrations are associated with virologic failure. Therefore higher doses might be needed. In addition, higher Cmax and/or exposure can lead to toxicity. As a result therapeutic drug monitoring is advised, or crushing the drug is a contra-indication based on the available data. It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion with omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering effect influencing the absorption of elvitegravir. It is probably a local gastrointestinal complexation phenomenon, similar to what has been observed with other HIV integrase inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation formers may be expected. Especially considering the active binding sites of elvitegravir which bind magnesium metal ion cofactors. Although there is data that STB can be ingested with a protein rich drink, it is unclear if foods or liquids containing high amounts of magnesium or other cations can cause this same interaction. Therefore this study will be conducted to investigate whether crushed and suspended STB and crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.
This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are: Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.