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Critical Care clinical trials

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NCT ID: NCT03773874 Completed - Pain Clinical Trials

Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units

ASCyD
Start date: February 12, 2018
Phase:
Study type: Observational [Patient Registry]

This study assess which Spanish intensive care units evaluate and record, in a standardized way, levels of pain, sedation / agitation, use of physical restraints and prevalence of delirium. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

NCT ID: NCT03706092 Completed - Aged Clinical Trials

Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Elderly Patients in a Surgical ICU

IATROAGE
Start date: August 1, 2018
Phase:
Study type: Observational

In order to optimize drug prescription and to reduce potentially inappropriate medications, a pharmaceutical analysis activity is conducted in our establishment for several years. Medical prescriptions are reviewed daily by pharmacists. This activity is developed in approximatively 84% of the hospital wards of the institution, and especially in the geriatric department. Drug induced adverse effects are frequently encountered in elderly people and ICU environment causes a high risk of iatrogenic events because of the complexity of care and of the severity of illness. The hypothesis of the study is that the intervention of pharmacists and geriatricians could improve the medical prescription in elderly patients by reducing avoidable drug interactions and thus by decreasing the risk of drug induced adverse effects. The primary objective of this study is to evaluate the impact of the intervention of pharmacists and geriatricians on medical prescription and on iatrogenic risk in elderly critically ill patients admitted in surgical ICU. The secondary objectives are (i) to describe the elderly patients population in surgical ICU, (ii) to analyze the impact of the ICU stay on medical prescription, (iii) to analyze the opportunities suggested by the pharmacists to optimize drug therapies and (iv) to assess the impact of drug prescription in the ICU on long-term disability. A prospective, observational, before-after study will be conducted from august 1, 2018 to February 1, 2020, in the surgical ICU of the hospital. Patients older than 70 years and admitted to surgical ICU will be eligible. This study will be conducted in 2 successive steps: (1) first step: without any intervention of pharmacists or and geriatricians (Baseline), (2) second step: all drug prescription during the ICU and the hospital stay will be analyzed by a pharmacist and a geriatrician, to decrease drug interaction and risk of drug related adverse effect. During each step, the demographic and medical data will be recorded. Medical prescriptions will be reviewed at ICU admission, at 96 hours after ICU admission and then every 4 days until discharge from the ICU. For each patient, the impact of the intervention on mid-term and long-term disability will be assessed during a geriatric evaluation by using adequate specific scale at hospital discharge and at 3 months after hospital discharge. All iatrogenic events will be collected and analyzed.

NCT ID: NCT03702296 Completed - Sleep Clinical Trials

Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?

Start date: August 29, 2018
Phase: N/A
Study type: Interventional

The importance of good sleep has been gaining interest in critically ill patients as poor sleep is associated with increased rates of delirium, non-invasive ventilation failure and stress to the patient. The use of earplugs and eye masks has been shown to result in longer sleep time and better sleep quality. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery will lead to improved sleep quality. Secondary outcomes include the level of noise intensity in the various monitored units, incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

NCT ID: NCT03666338 Completed - Rehabilitation Clinical Trials

Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization

SOMS-GCS
Start date: July 11, 2011
Phase: N/A
Study type: Interventional

Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.

NCT ID: NCT03628300 Completed - Sepsis Clinical Trials

Neurotoxicity Evaluation of Beta-lactams in Intensive Care Unit and Identification of the Risk Factors

NebuLar
Start date: January 1, 2017
Phase:
Study type: Observational

Beta-lactams are the most prescribed antibiotics in intensive care units. The lack of linearity between the dose administered and the exposition due to the very high variability of the pharmacokinetics in critically ill patients requires that the treatment be adapted on a case-by-case basis depending on the drug serum concentration. However, maximum concentrations not to be exceeded in order to limit beta-lactams toxicity are generally unknown. The main toxic risk of beta-lactams in intensive care is indeed neurological, but the neurotoxicity is probably underdiagnosed due to the variability of the signs observed, their time to onset, and confounding factors. Apart from recommendations for dose adjustment in the event of renal insufficiency, the procedures for the proper use of beta-lactams in intensive care are poorly established. The study presented here aims to assess the impact of the neurotoxic risk of beta-lactams in intensive care based on therapeutic drug monitoring, and thus to improve beta-lactam safety in critically ill patients. This is a prospective cohort study evaluating change in neurological status of patients admitted to the ICU and treated with a beta-lactam antibiotic with therapeutic drug monitoring. Neurological evaluation and scoring (Glasgow scale, CAM-ICU, Richmond agitation-sedation scale) and beta-lactam serum concentration assay are performed together 2 to 3 times a week.

NCT ID: NCT03597334 Completed - Critical Care Clinical Trials

Aerosol Therapy in Intensive Care Units

ATICU
Start date: July 9, 2018
Phase:
Study type: Observational [Patient Registry]

Unlike in the outpatient setting, delivery of aerosols to ICU patients may be considered complex, particularly in ventilated patients. Successful delivery of aerosolized medications to ICU patients depends upon the selection of the aerosol device and its installation position, the humidification condition, and the adjustment of the ventilator mode and parameters, etc. And there is currently little guidance or information on standards of practice in aerosol therapy. Purpose:The aim of the present work was to assess the frequency, modalities of aerosol therapy in critically ill patients either breathing spontaneously or undergoing invasive or noninvasive ventilation. Method:This prospective cross-sectional point prevalence study will be carried out over 14 days in several intensive care units. Centers are recruited on a voluntary basis. During the study period, characteristics of each ICU patient will be prospectively recorded each day. If patients receive inhaled medication during the study period, extensive data such as the selection of the aerosol device and its installation position will be recorded. Data will be entered into a database and analyses will be performed using SPSS soft ware. A p value lower than 0.05 is considered significant.

NCT ID: NCT03497559 Completed - Analgesia Clinical Trials

Music Use for Sedation In Critically Ill Children

MUSiCC
Start date: March 30, 2018
Phase: N/A
Study type: Interventional

Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.

NCT ID: NCT03475238 Completed - Nursing Caries Clinical Trials

Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units

NURSIE
Start date: March 29, 2018
Phase:
Study type: Observational

Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations. Those nursing cares require mobilization very frequently which expose critically ill patients to occurrence of serious adverse events (SAE) such as i) hemodynamic, neurologic, and respiratory variations ii) unplanned dislodgement (lines, drains, catheters, endotracheal tube..) Few study have evaluated relation between SAE occurence and several patient's, service's, health-care provider's caracteristics. We plan to analyse those factors to find some ways to prevent SAE occurence during nursing and hygiene cares.

NCT ID: NCT03454880 Completed - Critical Care Clinical Trials

Measuring Physical Activity Levels in Critical Care

ACTIVE
Start date: April 9, 2018
Phase:
Study type: Observational

The study will be a single-centre, prospective observational study to evaluate the use of a wearable accelerometer device to measure physical activity levels of patients within critical care.

NCT ID: NCT03432546 Completed - Chronic Pain Clinical Trials

Acute and Persistent Pain in ICU Patients

PAIN-ICU
Start date: April 6, 2018
Phase:
Study type: Observational

Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually. During ICU stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. After discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain. Only few studies with a focus on acute or persistent pain in ICU patients have been made, hence the incidence and risk factors for ICU-related pain is not very well known. Some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during ICU stay. Opioids are most often used for analgesics in intensive care. Because they may have several adverse effects the use must be based on validated pain scales. Many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain. This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.