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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07405333
Acronym
CEXIS
Enrollment
99
Registered
2026-02-12
Start date
2025-12-07
Completion date
2026-04-07
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease (CHD), Postoperative Respiratory Dysfunction, Postoperative Recovery After Cardiac Surgery

Keywords

Coughing Exercises, Incentive Spirometry, Congenital Heart Disease, Respiratory Function, Recovery, cardiac surgery, pediatric

Brief summary

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.

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.

Interventions

BEHAVIORALCoughing 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.

DEVICEIncentive 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.

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.

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

this is a parallel-assignment randomized interventional study with three arms: coughing exercises, incentive spirometry, and standard care. Participants will remain in their assigned group throughout the study period, receiving the allocated intervention along with standard postoperative care

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Function Score.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.

Secondary

MeasureTime frameDescription
Postoperative Recovery Indicators Assessed by Clinical and Functional ParametersBaseline, postoperative day 1, and postoperative day 7Postoperative 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.
Length of Intensive Care Unit (ICU) StayFrom ICU admission after surgery until ICU discharge, up to postoperative day 14The 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..
Arterial Blood Gas (ABG) ParametersBaseline (prior to intervention) and 24, and 48 hours after interventionArterial 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.

Countries

Iraq

Contacts

CONTACTrusul khalid khadim, MSc
rusal.khaled1606a@conursing.uobaghdad.edu.iq96407702612183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026