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NCT Number: NCT07484178

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Change in Dyspnea Severity

    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)

  2. Change in Pulmonary Function

    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.

Secondary outcomes

  1. Change in Oxygen Saturation (SpO₂)

    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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Misha Mazhar, MSN

CONTACT

[email protected]

+923026958223

Umar Iqbal, ACCA

CONTACT

[email protected]

+923009758649

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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