Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Dyspnea Severity
研究概览
简要总结
The goal of this clinical trial is to evaluate whether respiratory nursing interventions can improve respiratory outcomes in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are:
Do respiratory nursing interventions improve dyspnea levels measured by the Modified Medical Research Council (mMRC) Dyspnea Scale? Do these interventions improve oxygen saturation and pulmonary function (FVC, FEV1, and FEV1/FVC ratio)?
Researchers will compare patients receiving respiratory nursing interventions plus routine hospital care with patients receiving routine hospital care alone to determine whether the interventions improve respiratory outcomes.
Participants will:
Undergo baseline assessment using the mMRC Dyspnea Scale, pulse oximetry, and pulmonary function tests.
Receive either respiratory nursing interventions (deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake) along with routine care or routine hospital care alone.
Be reassessed after the intervention period using the same respiratory outcome measures.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder and a leading cause of morbidity and mortality globally. In Pakistan, the prevalence of COPD is increasing due to factors such as tobacco smoking, environmental pollution, and the use of biomass fuels. Patients hospitalized with acute exacerbation of COPD often experience worsening respiratory symptoms including dyspnea, reduced oxygen saturation, and impaired pulmonary function.
Respiratory nursing interventions such as deep breathing exercises, chest percussion, postural drainage, and adequate hydration through lukewarm water intake have been reported in international literature to improve airway clearance, enhance ventilation, and support better respiratory outcomes. Despite this evidence, there is limited research conducted in Pakistan to evaluate the effectiveness of these interventions in hospitalized COPD patients.
This randomized controlled study aims to assess the add-on effects of respiratory nursing interventions on respiratory outcomes among patients with acute exacerbation of COPD. A total of 68 patients will be recruited through convenience sampling. Eligible participants will be randomly allocated into two groups: an intervention group and a control group, with 34 participants in each group, using the lottery method.
The study will be conducted in three phases: assessment, intervention, and evaluation. Baseline respiratory outcomes will be assessed prior to intervention. Participants in the intervention group will receive respiratory nursing interventions in addition to routine hospital care, while the control group will receive routine hospital care only. Outcomes will be measured using the Modified Medical Research Council (mMRC) Dyspnea Scale, pulse oximetry, and pulmonary function tests including FVC, FEV1, and FEV1/FVC ratio. Data will be analyzed using an independent t-test to determine the effectiveness of the respiratory nursing interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cases of COPD admitted for acute exacerbation according to Global Initiative for Chronic Obstructive Lung Disease.
- •Adults aged > 40 years (WHO, 2023; GOLD, 2024).
- •Both genders (male & female).
- •Hemodynamically stable at the time of enrollment in terms of vital signs (e.g., blood pressure > 90/60 mmHg, heart rate between 60-100 bpm) to safely undergo nursing interventions without acute risk (Jarhyan et al., 2021).
- •Dyspnea Grade ≥ 2 on the mMRC Scale (Mahler and Wells, 1988).
- •Blood Oxygen Saturation (SpO₂) ≥ 88% on Room Air or Oxygen Therapy (O'Driscoll, 2017).
排除标准
- •Dyspnea due to cardio-pulmonary disease or other co-morbidities.
- •Patients on mechanical ventilation and ICU admission.
- •Patients with mental disorders.
- •Patients with upper airway obstruction.
研究组 & 干预措施
Control Arm
Control arm will receive standard care only.
Experimental Group will receive nursing intervention
Experimental Group will receive nursing interventions such as deep breathing exercise, chest percussions, postural drainage and lukewarm water intake along with standard care
干预措施: Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care. (Other)
结局指标
主要结局
Change in Dyspnea Severity
时间窗: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in dyspnea severity measured using the Modified Medical Research Council Dyspnea Scale to assess the dyspnea affecting functioning in patients with acute exacerbation of Chronic Obstructive Pulmonary Disease. 0-5 Scale (0 Minimal functioning impairment and 4 maximum functioning impairment)
Change in Pulmonary Function
时间窗: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in pulmonary function parameters including Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), and FEV1/FVC ratio measured using pulmonary function tests to determine the impact of respiratory nursing interventions in COPD patients with acute exacerbation. Normal is greater than 70%. Less than 70% means decreased pulmonary function.
次要结局
- Change in Oxygen Saturation (SpO₂)(Baseline to Day 4 of hospitalization or at discharge if earlier.)
研究者
Misha Mazhar
MSN Student
University of Health Sciences Lahore