Comparing the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease, A randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 1. Assessment of improvement in the peak expiratory flow rate, blood gas analysis results and vital signs including heart rate, respiratory rate and oxygen saturation among participants in the study group.
研究概览
简要总结
Background: Chronic obstructive pulmonary disease, characterised by chronic respiratory symptoms like dyspnoea, cough, sputum production and is often associated with episodes of acute exacerbations which may occur due to various triggers like bacterial or viral infections, exposure to pollutants like biomass fuels, crop residues, woods etc. various treatment modalities have been implicated in the management of these episodes of acute exacerbations of COPD. This randomized control trial aims to compare the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease in this sample population.
Methods: The study will be conducted in within Department of medicine, at AVBRH, a tertiary care teaching hospital placed within geographic region of Wardha District. Study is done when approved via institute moral committee (applied for).The participants with acute exacerbation of chronic obstructive pulmonary disease will be randomized using a computer generated random sequence into two groups, Group A receiving intravenous injection of magnesium sulphate as a single dose on presentation to emergency department and Group B receiving nebulisation with magnesium sulphate three times at an interval of 30 minutes each time (i.e on presentation, at interval of 30 minutes and then at 60 minutes from the time of presentation, as an adjunctive along with standard treatment for acute exacerbations of COPD. Various investigations will be conducted at baseline and throughout the study period, including peak expiratory flow rate (PEFR), arterial blood gas analysis (ABG), chest x ray, complete blood count and CURB-65, q SOFA and CAT scores will be assessed.
Expected Results: It is anticipated that intravenous magnesium sulphate as an adjunctive in treatment of acute exacerbation of chronic obstructive pulmonary disease will lead to improvement in bronchospasm and improve dyspnoea score, decrease the need for hospitalisation and / or duration of hospital stay among participants with acute exacerbation of COPD whereas nebulized magnesium sulphate may reduce the number of ICU admissions and improve dyspnoea. Positive effect of intravenous and nebulized magnesium sulphate as an adjunct in management of acute exacerbation of COPD and study outcomes are expected. Adherence to the intervention protocol and the safety and tolerability of intravenous and nebulized magnesium sulphate will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of chronic obstructive pulmonary disease experiencing a moderate acute exacerbation according to the ROME proposal.
排除标准
- •Patients requiring immediate endotracheal intubation on arriving at the emergency medicine department.
- •Patients with severe symptoms like breathlessness who are unable to blow into the PEFR device.
- •Patients with altered sensorium or reduced levels of consciousness unable to blow in the PEFR device.
- •Patients in shock with systolic blood pressure less than 100 mmhg Patients with dyselectrolytemia contraindicating the use of magnesium sulphate like hyperkalaemia and hypocalcaemia Patients with renal failure and heart block.
结局指标
主要结局
1. Assessment of improvement in the peak expiratory flow rate, blood gas analysis results and vital signs including heart rate, respiratory rate and oxygen saturation among participants in the study group.
时间窗: At presentation and at 60 minutes after presentation.
次要结局
- 2. To monitor the symptomatic relief based on CAT score and assess the need for ICU admission, duration of hospital stay, need for invasive or non-invasive mechanical ventilation along with q SOFA score and CURB-65 score in these patients so as to determine the mortality and morbidity among the participants from the study group(at presentation and 60 minutes after presentation.)
研究者
Dr Nidhi Anilkumar Bardiya
Datta Meghe Institute of Higher Education and Research