Active clinical trials for "Respiratory Insufficiency"

The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation via an endotracheal tube as part of their treatment for respiratory failure. Participants will be allocated to either a normal blood oxygen target group or a lower than normal blood oxygen target group. The primary purpose of the study will be to assess the feasibility of recruiting complex patients who lack capacity into a clinical trial in which oxygenation is being assessed, and that the clinicians responsible for these patients are able to deliver the intervention effectively. The safety of using a lower than normal blood oxygen target will also be assessed and blood samples taken for subsequent investigation of the biological mechanisms underlying the observed changes. Participants will be randomised (1:1) into either an intervention or control group. The intervention in this trial is tightly controlled administration of oxygen to patients to achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target for the control group represents a normal SpO2, whilst that in the intervention group is lower than what is considered to be normal. It should be noted that although lower than normal, this SpO2 is close to what the general public experience when travelling by pressurised aircraft as the fractional inspired oxygen concentration in that situation is only 0.15-0.17 (15-17%). The controlled oxygen administration would commence as soon as possible after admission to the critical care unit and end following removal of the participant's artificial breathing tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the nature of the intervention. Those analysing the data will be blinded to the intervention.

Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. As non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques. The aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. Initially, a Delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes. In the single-arm therapeutic exploratory trial (phase II), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. The results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase III).

The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min

Patients are at risk of respiratory depression after having surgery. The medications that patients are treated with to control their pain can impair their breathing and this can progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical wards is usually done every 4 hours and this may be insufficient to identify and manage many cases of respiratory depression. The aim of this study is to determine the impact on safety and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety outcomes. Respiratory depression is a serious complication of pain treatment that can lead to patient complications and death. The level of monitoring available in hospitals by nursing staff is insufficient to manage this problem. If this new monitoring technology works as designed then patient safety can be improved while maintaining effective pain therapy.

This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.

The U.S. Environmental Protection Agency has traditionally examined the effects of single pollutant exposure on human health outcomes; however, to provide a better assessment of pollutant exposure-associated effect on human health the Agency is moving toward a multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air quality standards (NAAQS) criteria pollutants that are major constituents of ambient air pollution. This study will address the Agency's goals by investigating the cardiopulmonary health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The findings of this study will provide data that will inform risk assessment models for O3 and NO2 exposures. Additionally, the findings will provide insight into how the human health effects of multi-pollutant exposures differ from those of single pollutant exposures.

Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. However, NIV is not always successful and half of children in respiratory failure finally require invasive ventilation. A major cause of NIV failure is the ventilator inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted ventilatory assist) improves the detection of patient efforts during mechanical ventilation. The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and therefore permits to unload the patient ventilatory efforts.

Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse as part of clinical care. The purpose of this study is to determine how often tooth brushing should occur for adult patients with breathing tubes (mechanical ventilation), balanced with equivalence and safety.

Vibration therapy is used for different indications in rehabilitation and sports medicine. So far, vibration therapy has not been investigated within the ICU setting. The investigators created this setting to show safety and applicability of vibration therapy in ICU patients. 30 patients will be stimulated by vibration therapy on two separate days during their ICU stay. Three collectives of equal size will be observed: One with patients on mechanical ventilation without signs of infection or suspected intracranial pressure problems, a second one with patients on mechanical ventilation in addition to signs of systemic inflammation but absence of suspected intracranial pressure problems, and a third one with patients on mechanical ventilation, signs of systemic inflammation in addition to presence of controlled intracranial pressure problems. Typical parameters of hemodynamic status, intracranial pressure and energy metabolism will be recorded for a defined period of time before, during and after vibration therapy itself. Vibration therapy will be combined with protocol based physiotherapy. Our aim is to show the effects of vibration therapy in ICU patients and its safe applicability. ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg, randomized chosen. Measuring the local skeletal muscle metabolism will be done by microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration therapy combined with electrical muscle stimulation.

This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.