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NCT06008210
This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.
NCT04848012
Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes. Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath. The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator. Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home. Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.
NCT04018729
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent. Mesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema. Based on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.
NCT05539547
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that results in a mixture of small airway disease and parenchymal destruction, changes that are characteristic of emphysema. COPD is also characterized by persistent airflow limitation, an aspect which is noted to be a major cause of morbidity and disease burden worldwide. One in every 8 patients who suffer an exacerbation requires to be admitted to the hospital. Due to repercussions that arise both because of the systemic effects of COPD and also the aggravating factors due to the exacerbation, new adjuncts to treatment are being researched. NMES is a non-invasive and non-addictive means of muscle contraction and was introduced as a rehabilitation means post muscle injury, surgery, and eventually in certain diseases and its use in the treatment of patients with COPD is being looked into. This research study shall adopt a quantitative approach. A Randomised Control Trial (RCT) shall be used to investigate the effect of Neuromuscular Electrical Nerve Stimulation on quadriceps muscle strength and endurance. Approximately 103 patients shall be randomly enrolled in the control group and the experimental group. The control group shall receive Physiotherapy as already provided by physiotherapists including chest and mobility exercises. The experimental group shall undergo Physiotherapy with the addition of NMES. To assess the effect of NMES on quadriceps strength and endurance, quadriceps strength shall be tested through the use of a hand-held dynamometer. Endurance shall be tested through a quadriceps endurance test which requires the leg to be extended against a weight corresponding to 70% of the 1 repetition maximum with a pace of 12 movements per minute, a test which will be stopped when the patient can no longer perform the movement despite strong verbal prompting and encouragement and the standardised 1-minute sit-to-stand. All tests are to be conducted before the intervention, hence on admission to the local general hospital and prior discharge to a maximum of 30 days from the date of admission. All tests shall be done in the patients' ward setting. Also, a diagnostic ultrasound scan of this group of muscles shall be performed upon admission and before discharge by a consultant radiologist at the radiology department. The Borg scale shall be used to assess the shortness of breath of the patients following the 1-minute sit-to-stand.
NCT02962999
Chronic obstructive pulmonary disease (COPD) patients often undergo thoracic surgery due to lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery aggravates hypoxia and hypercapnia increasing intrapulmonary shunt and dead space.Ketamine provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of ketamine on arterial oxygenation, the shunt fraction and the lung mechanics in patients with COPD who administered OLV because of thoracic surgery. Thirty patients with COPD who undergo thoracotomy for lung lobectomy will be included in this study. Patients will be randomly divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be administered 1 mg/kg ketamine bolus, then 0,5 mg/kg/hour ketamine infusion after the induction, CG will be administered sline bolus, then saline infusion. Peak airway pressure (Ppeak), plato airway pressure (Pplato), static compliance, shunt fraction, PaO2/FiO2 and arteriel blood gas values (Pa02, PaC02) will be recorded before initiation of OLV and 30 minutes intervals after initiation of OLV.To evaluate the postoperative pulmonary complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be recorded 20 minute after arrival at postoperative care unit. Patients will be evaluated for pneumonia, atelectasis and acute lung injury at postoperative 72 h and findings will be recorded. 30 day mortality will be recorded.