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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Exacerbation Copd
• Intervention / Treatment: Other: Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Misha Mazhar, MSN; Phone Number: +923026958223; Email: mishamazhar786@gmail.com
• Study Contact Backup: Name: Umar Iqbal, ACCA; Phone Number: +923009758649; Email: umariqbal639@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • UHS
      • Contact: Samina Kausar, Phd Nursing; Phone Number: +923334072790; Email: ion_uhs@uhs.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Control arm will receive standard care only.
Experimental: 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	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, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dyspnea Severity	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)	Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in Pulmonary Function	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.	Baseline to Day 4 of hospitalization or at discharge if earlier.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oxygen Saturation (SpO₂)	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%.	Baseline to Day 4 of hospitalization or at discharge if earlier.

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore
• Investigators: Study Director: Samina Kausar, Phd Nursing, UHS

Publications and helpful links

General 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.

Helpful Links

• Management of severe acute exacerbations of COPD: an updated narrative review
• Effect of Respiratory Rehabilitation Nursing Interventions on Acute Exacerbation Symptoms of Chronic Obstructive Pulmonary Disease Among Hospitalized Geriatric Patients

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Acute Exacerbation; Respiratory outcomes; Nursing Intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: UHS/DPS-26/575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No