Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Official title

Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Control Trial

Overview

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.

Detailed description

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.

Interventions

• Other Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.
  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, impro

Primary outcome measures

• Change in Dyspnea Severity [Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.]
• Change in Pulmonary Function [Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.]

Secondary outcome measures (1)

• Change in Oxygen Saturation (SpO₂) [Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Pakistan · 1 center

• UHS — Lahore

Publications

• Wu X, Zhang H, Chen J. Comprehensive expectoration nursing in elderly patients with pulmonary infection and its influence on respiratory function. Am J Transl Res. 2021 Nov 15;13(11):12965-12972. eCollection 2021. PMID 34956512

Identifiers

NCT: NCT07484178 · UHS/DPS-26/575

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗