Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. (CEXIS)

May 7, 2026 updated by: Rusul Khalid Kadim, University of Baghdad

Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Outcomes and Postoperative Recovery Among Children Undergoing Cardiac Surgery.

This study examines the effects of coughing exercises and incentive spirometry (IS) on lung function and recovery in children who undergo heart surgery. The main goals are to see:

How coughing exercises and IS affect breathing and lung function after surgery? How these exercises influence overall recovery after surgery? Children who participate will be randomly assigned to one of three groups: coughing exercises, IS, or standard care. Those in the exercise groups will perform their assigned breathing exercises every 3 hours for the first 3 days after surgery. Daily check-ups will be conducted to monitor their progress, lung function, and oxygen levels.

The study will measure breathing ability, oxygen levels, and recovery milestones to find out which method is most effective in preventing lung complications and helping children recover faster.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial evaluates the effects of coughing exercises and incentive spirometry (IS) on postoperative respiratory outcomes and recovery in children undergoing elective cardiac surgery with cardiopulmonary bypass.

The study aims to answer:

How do coughing exercises and IS influence lung function and breathing after surgery? How do they affect overall recovery, including physical comfort, oxygenation, and prevention of pulmonary complications?

Eligible children aged 6 to 18 years will be randomly assigned to one of three groups:

Coughing exercises group Incentive spirometry group Standard care group Children in the intervention groups will perform the assigned exercises every 3 hours for the first 3 days after surgery. All participants will receive daily monitoring, including vital signs, oxygen saturation, lung function assessment, and observation of postoperative recovery indicators such as feeding tolerance and mobility.

The study will assess primary outcomes such as postoperative respiratory function using a standardized respiratory score, and secondary outcomes including postoperative recovery indicators (quality of recovery scores), incidence of pulmonary complications, and length of stay in the pediatric intensive care unit (ICU).

This research will help identify the most effective method for improving respiratory outcomes, reducing complications, and supporting faster recovery in children after cardiac surgery.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Iraq
      • Baghdad, Baghdad Governorate, Iraq
      • Baghdad, Baghdad Governorate, Iraq
    • Karbala Governorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Crit

  • Children aged 6 to 18 years scheduled for elective cardiac surgery.
  • Postoperative extubation within 24 hours and judged clinically stable to begin respiratory therapy.
  • Hemodynamically stable.

Exclusion Criteria:

  • Pre-existing moderate-to-severe chronic lung disease requiring baseline oxygen therapy.
  • Neuromuscular disorders significantly impairing cough/inspiratory effort.
  • Emergency surgery, ongoing major bleeding.
  • Prolonged mechanical ventilation >72 hours or tracheostomy on admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coughing Exercises
participants in this arm will receive structured postoperative coughing exercises under professional supervision. The exercises include deep breathing followed by effective coughing techniques to enhance airway clearance, promote lung expansion, and prevent postoperative pulmonary complications. The intervention will be performed every 3 hours for three days after cardiac surgery in addition to standard postoperative care.
Behavioral: Coughing Exercises
participants will receive structured postoperative coughing exercises supervised by trained healthcare professionals. The intervention includes instruction on effective deep breathing followed by directed coughing to enhance airway clearance and prevent secretion retention. Exercises will be performed every 3 hours for three consecutive days after cardiac surgery, in addition to standard postoperative care.
Experimental: Incentive Spirometry (IS)
Participants in this arm will receive postoperative incentive spirometry under professional supervision. Children will be instructed to perform slow, deep inhalations using an incentive spirometer to promote lung expansion, improve ventilation. The intervention will be performed 15 times every 3 hours for three days after cardiac surgery in addition to standard postoperative care.
Device: Incentive Spirometry
participants will perform postoperative incentive spirometry using a standard incentive spirometer under professional supervision. Children will be instructed to perform slow, deep inspirations with visual feedback to promote lung expansion and alveolar recruitment. The intervention will be conducted 15 times every 3 hours for three days after surgery, alongside standard postoperative care.
Active Comparator: Standard Postoperative Care
Participants in this arm will receive standard postoperative care following cardiac surgery without additional structured respiratory physiotherapy interventions. Standard care includes routine medical and nursing management according to hospital protocols, such as oxygen therapy, pain management, monitoring of vital signs, and general postoperative mobilization as tolerated.
Other: Standard Postoperative Care
Participants will receive routine postoperative care according to institutional protocols following cardiac surgery. This includes standard medical and nursing management such as oxygen therapy, pain control, monitoring of vital signs, and mobilization as tolerated, without additional structured respiratory physiotherapy interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Function Score.
Time Frame: Baseline, 1 hour after intervention, 3 hours, 6 hours, 24 hours, 48 hours, and 72 hours.
A composite postoperative respiratory function score assessed using standardized pediatric respiratory severity score, including respiratory rate (breaths/min), oxygen saturation measured by pulse oximetry (SpO₂, %), presence of wheezing (yes/no), use of accessory respiratory muscles (yes/no), and feeding tolerance. Higher scores indicate better respiratory function.
Baseline, 1 hour after intervention, 3 hours, 6 hours, 24 hours, 48 hours, and 72 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Recovery Indicators Assessed by Clinical and Functional Parameters
Time Frame: Baseline, postoperative day 1, and postoperative day 7
Postoperative quality of recovery assessed using the Pediatric Quality of Recovery (PQoR) scale, which evaluates postoperative pain, comfort, emotional status, physical activity, and feeding tolerance through age-appropriate assessment and caregiver reporting. Higher scores indicate better postoperative recovery.
Baseline, postoperative day 1, and postoperative day 7
Length of Intensive Care Unit (ICU) Stay
Time Frame: From ICU admission after surgery until ICU discharge, up to postoperative day 14
The duration of stay in the pediatric intensive care unit following cardiac surgery, calculated in days from ICU admission to ICU discharge based on hospital medical records..
From ICU admission after surgery until ICU discharge, up to postoperative day 14
Arterial Blood Gas (ABG) Parameters
Time Frame: Baseline (prior to intervention) and 24, and 48 hours after intervention
Arterial blood gas analysis will be used to evaluate changes in oxygenation and ventilation status following the cough exercise and incentive spirometry intervention. The measured parameters include partial pressure of oxygen (PaO₂), partial pressure of carbon dioxide (PaCO₂), bicarbonate (HCO₃-), and oxygen saturation (SaO₂). Measurements will be obtained using standard arterial sampling procedures and analyzed according to hospital laboratory protocols.
Baseline (prior to intervention) and 24, and 48 hours after intervention
postoperative complications
Time Frame: From the first postoperative day until hospital discharge (up to 7 postoperative days).
Assessment of postoperative complications among pediatric patients following cardiac surgery, including atelectasis, pneumonia, pleural effusion, pneumothorax, respiratory distress, and others during the postoperative period.
From the first postoperative day until hospital discharge (up to 7 postoperative days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2025

Primary Completion (Estimated)

August 7, 2026

Study Completion (Estimated)

October 7, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOB-NUR-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to the sensitive nature of pediatric health information and to protect participant confidentiality. The study involves children undergoing cardiac surgery, and sharing detailed clinical data could risk identification of participants despite de-identification measures. Additionally, no institutional approval has been obtained for secondary use of these data..

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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