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Critical Illness clinical trials

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NCT ID: NCT01634451 Completed - Critical Illness Clinical Trials

Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care

DESIST
Start date: June 2012
Phase: N/A
Study type: Interventional

Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done through implementation of "care bundles". Ensuring that ICU patients get the correct amount of sedation (medicine that makes patients sleepy) is part of this bundle, but is proving the most difficult to get right. It's important healthcare staff (nurses and doctors) get sedation levels correct because too much sedation is linked with increased hospital acquired infections (HAIs), longer intensive care (ICU) and hospital stays, and possibly higher death rates. This quality improvement project will develop and introduce three interventions that may improve sedation practice: first, an ICU sedation education package; second, feedback of sedation-related performance data (graphs and charts); and third, introduction of a CE (Conformité Européenne - With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of European regulations) marked new technology designed to improve sedation management. The investigators will study the effect these interventions, in different combinations, have on sedation management and quality in the participating ICUs. Eight ICUs in Scotland will take part in the project, pairs (2 ICUs) will be assigned randomly to different combinations as follows: 1.Enhanced education alone, 2. Education plus process/outcome measure feedback (graphs and charts), 3. Education plus introduction of a new sedation monitoring technology, or 4. Education,process/outcome measure feedback, and sedation monitoring technology. The investigators will evaluate which combinations of education, feedback, and technology provide the most patient benefit in the NHS. In addition both nursing & medical staff will be observed in clinical practice & interviewed about their clinical practice to increase understanding about sedation management from different view points and inform the education package content. These data will also help implement the findings after the research is completed if a benefit is found.

NCT ID: NCT01633606 Completed - Critical Illness Clinical Trials

Drawing the Line Between Medium Care and Intensive Care. A Prospective Observational Study Based on the Nursing Activities Score

Start date: February 2013
Phase: N/A
Study type: Observational

The aim of the study is to develop a screening instrument, based on the nursing activities score, by which we can distinguish medium care patients from the intensive care patients in terms of nurse staffing. The main study question is: What is the most discriminative NAS cut off for medium care patient? Each nursing shift the NAS and TISS 28 scores will be calculated for each patient who is admitted to the 8 participating units. Nurses will be asked to answer 3 questions (see detailed description here under)at the end of their working shift concerning each patient appointed to them. Each morning medical staff and head nurses will be asked 2 questions (see detailed description here under) for concerning patient admitted to there ward. In order to determine the NAS cut off for medium care patient, all morning questionnaire scores will be compared to the NAS an TISS28 scores of that same morning. Secondary study questions are: - Can NAS score based on one nursing shift predict the severity of care in the subsequent nursing shift? - Is there a difference in appreciation of severity of care between nurses, head nurses and medical staff? - Which variables influence the perception of severity of care? - How does NAS relate to TISS28, APACHE and NEMS?

NCT ID: NCT01632813 Completed - Critical Illness Clinical Trials

Leuven Growing Into Deficit Follow-up Study

Leuven-GID
Start date: July 2012
Phase: N/A
Study type: Observational

The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.

NCT ID: NCT01628185 Completed - Critical Illness Clinical Trials

Pain Assessment in the Intensive Care Unit

Start date: January 2012
Phase: N/A
Study type: Observational

Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. Consequently, pain assessment is highly challenging in these ICU patients. This is a prospective observational study assessing 3 behavioral pain scales in the ICU. The hypothesis of this proposal is that one of the three ICU pain scales has a more important reliability than the others. Such a scale could be recommended to be used to measure pain intensity in ICU patients not able to communicate.

NCT ID: NCT01610076 Completed - Critical Illness Clinical Trials

Code Status Video in the Intensive Care Unit: Video Assisted Patient Education

Start date: November 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-center, randomized control trial of a code status video as an educational tool in the intensive care unit. Subjects are stratified by patient or surrogate and are randomized to either watch an educational video on code status or not watch the video. They are then asked knowledge base questions regarding code status as well as questions pertaining to comfort regarding code status. Participants randomized to watch the video are also asked questions related to acceptance of the video.

NCT ID: NCT01607723 Completed - Critical Illness Clinical Trials

"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

Start date: May 2012
Phase: Phase 3
Study type: Interventional

Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

NCT ID: NCT01607060 Completed - Constipation Clinical Trials

Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.

Start date: September 2008
Phase: Phase 3
Study type: Interventional

MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent complication in critical ill patients. The disaccharide lactulose has a laxative osmotic activity. Given the scant evidence and the potential risk associated with constipation in seriously ill patients, this study aims to assess the impact of laxative therapy in the prognosis of critically ill patients. Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction and if treated can result in improved prognosis for critically ill patients.

NCT ID: NCT01589575 Completed - Depression Clinical Trials

Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

StressRéa
Start date: September 2012
Phase: N/A
Study type: Observational

The main objective of this study is to compare the rate of reported anxiety / depression (HADS >= 8) among spouses and other family members in ICU patients.

NCT ID: NCT01585909 Completed - Critical Illness Clinical Trials

Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

Start date: July 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.

NCT ID: NCT01581957 Completed - Critically Ill Clinical Trials

Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients

SPIRIT
Start date: December 2012
Phase: N/A
Study type: Interventional

Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient. This pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.