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NCT05819164
The oximeter is an instrument for monitoring patients receiving oxygen therapy. It displays pulse oxygen saturation (SpO2), which is a reflection of arterial oxygen saturation (SaO2). An accurate SpO2 value is essential for optimal management of the O2 flow delivered to patients. Several factors can influence this measurement and the choice of ventilatory support: the type of oximeter used, skin pigmentation and the oxygenation goal. The objective of our study is to evaluate the impact of the oxygenation goal and the oximeter used on oxygen flows in patients with COPD (or with hypercapnia, or at risk of hypercapnia) and in patients without COPD (in particular pneumonia, pulmonary fibrosis and other pathologies) Our hypothesis is that the SpO2 target and oximeter used will have an impact on oxygen flows and that these effects will be synergistic in these different populations.
NCT07351929
The investigators have developed a new counseling service that focuses on the emotional distress experienced by people living with COPD. The service has been specially developed for patients who have experienced a deterioration in their lung condition (known as an acute exacerbation of COPD). The new program is led by an APN team. Other professionals are involved in the program, such as medical staff and physiotherapists. The new counseling service lasts three months. Patients will receive ten counseling sessions with a specialized nurse. The overall objective of the study is to assess the feasibility of the newly developed emotional-distress-based integrated care programme.
NCT05443321
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.
NCT05897125
Transitions of Care (TOC) between hospital, ambulatory, and home settings for high-risk, frequently hospitalized adults with chronic diseases, such as chronic obstructive pulmonary disease (COPD) are complex, costly, and vulnerable to safety threats and poor health outcomes. One potential solution to address this gap in care is the Transitional Care Model (TCM), which utilizes a patient-centered approach with in-home interventions; since in-person in-home visits are costly, using innovative telehealth, such as virtual visits via teleconferencing may be just as effective with greater feasibility, scalability, and sustainability, particularly in the post-COVID-19 era as has been seen the rapid expansion of these technologies. With a transdisciplinary team of experts from cognitive science, care transitions/handoffs, human factors engineering, design, implementation science, and health services research, the study team proposes to implement and evaluate via a randomized clinical trial the "TELE-TOC: Telehealth Education: Leveraging Electronic Transitions Of Care for COPD patients," intervention which includes a virtual visit, pharmacy-based, in-home intervention for COPD patients to improve medication use and patient outcomes among a population at high risk for readmission and medication safety events.
NCT04217746
Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients. The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.
NCT05233137
Patients with COPD lose muscle strength during acute exacerbations of COPD (AECOPD) which interferes improving the recovery of physical activity (PA) after an AECOPD. Resistance training can reverse this process. An exercise training program with the focus on resistance training is essential in minimizing the long-term effects of AECOPD as it may help to accelerate the gain in PA in the weeks after an acute event. Therefore, it is important that such programs are embedded at the right moment (i.e. immediately after an AECOPD) and in a setting accessible to the patient (i.e. primary care). The efficacy and effectiveness of implementing such training programs will be assessed in the present study.
NCT05958563
Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".
NCT06347536
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality. Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed. A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.
NCT03564236
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations. Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown. Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT. Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating. Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included. Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care. Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.
NCT06000696
The objective is to conduct a pilot-feasibility trial of the "Healthy at Home" program, a multimodal intervention aimed at preventing acute care needs among COPD patients. The program will feature a digital platform and virtual pulmonary rehabilitation to facilitate complex care management of UMass Memorial Health Patients
NCT04034901
Background : Acute exacerbations of COPD (Chronic Obstructive Pulmonary Disease) are frequent events in the course of the disease and they can deteriorate the respiratory function of the patients, impact their quality of life and even potentially threaten their life. It is therefore crucial to prevent these exacerbations from occurring. Aim of the study : Investigate how cardiorespiratory parameters of COPD patients differ between exacerbation phases and their nominal state in order to identify predictors of COPD exacerbations. Study design : Patients admitted at one of the investigation centers on a suspicion of COPD exacerbation will be enrolled on a voluntary basis. Enrolled patients' cardiorespiratory parameters will be monitored with a connected wrist-worn pulse oximeter (BORA Band) during the hospitalisation phase and one month after they have been discharged. Setting : 4 investigative centers across Brittany Patients : 50 patients will be enrolled in the study
NCT06514599
Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) are one of the chief causes for admission to Emergency Department. AECOPD is a significant cause for mortality and morbidity worldwide. Emergency Medicine Physicians frequently manage these patients. Predicting the severity and possible prognosis of AECOPD is an important task for Emergency Medicine Physicians as treatment options and aggressiveness may depend on these predictions. In our study we aimed to compare different biomarkers such as Procalcitonin, Pro-Brain Natriuretic Peptide (Pro-BNP) and C-Reactive Protein (CRP) on their efficacy at predicting the severity and prognosis of AECOPD. We analyzed the data of the selected 196 patients with the diagnosis AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guide who were admitted to our Emergency Department between 15/02/2023 and 15/02/2024.
NCT06495086
The investigators investigated the efficacy and safety of High Flow Nasal Cannula (HFNC) at different flow rates compared to non-invasive ventilation (NIV) in patients presenting to the emergency department (ED) with acute exacerbations of Chronic obstructive pulmonary disease (COPD) who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure. Specifically, the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide (PaCO2) levels and hospital stay duration and would be associated with greater patient comfort than NIV.
NCT03119727
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)
NCT05687396
In addition to conventional pulmonary rehabilitation, virtual reality will be applied during the hospitalization period of individuals hospitalized for COPD exacerbation. It is aimed to get more efficiency from the interventions in this short time.
NCT05153122
The study will include daily SenseGuard measurement of patients hospitalized with exacerbations of COPD. from admission to discharge. In parallel clinical evaluation of patient's respiratory condition was done daily by routine tests and questionnaires.
NCT06212180
A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.
NCT06211920
The goal of this clinical trial is to test if treatment with prehospital Non-invasive ventilation (NIV) for patients with acute respiratory failure (ARF), due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) based on in-hospital criteria, should be used in the prehospital setting. This is performed with the introduction of prehospital arterial blood gas analyzation. The primary objective is: • To determine if early prehospital applied NIV together with standard medical treatment will affect arterial pH at hospital arrival in patients with ARF due to AECOPD. Participants in the intervention will receive Non-invasive ventilation together with standard medical treatment. The intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.
NCT05852327
To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.
NCT05012033
This is a pilot study to investigate serum prednisolone profiles in: * Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting. * Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone. The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone. The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.