UHS
Lahore, Punjab Province, Pakistan
NCT Number: NCT07484178
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.
Trial opening soon.
Get Notified40 year and older
All sexes
Interventional
Not applicable
Lahore, Punjab Province, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention consists of a structured package of respiratory nursing interventions provided in addition to routine hospital care for patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It includes deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake, administered by trained nursing staff according to a standardized protocol during hospitalization. These combined interventions aim to enhance airway clearance, improve ventilation, and reduce mucus viscosity, thereby improving dyspnea, oxygen saturation, and pulmonary function outcomes. The integration of multiple respiratory nursing techniques as an add-on to routine care distinguishes this intervention from standard management practices.
Time frame: 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)
Time frame: 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.
Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in oxygen saturation levels measured by pulse oximetry to evaluate the impact of respiratory nursing interventions on oxygenation status in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease. Low Saturation Less than 88% and Normal greater than 95%.
Contact information is provided by the study sponsor or research team.
Misha Mazhar, MSN
CONTACT
Umar Iqbal, ACCA
CONTACT
University of Health Sciences Lahore
Other
Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Control Trial
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