Congenital Heart Disease (CHD)CEXISNCT07405333
Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery.
A study testing Coughing Exercises, Incentive Spirometry and Standard Postoperative Care in people with Congenital Heart Disease (CHD) and Postoperative Respiratory Dysfunction, run by University of Baghdad at 4 sites in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Postoperative Respiratory Dysfunction, Postoperative Recovery After Cardiac Surgery
- What is being tested?
- Coughing Exercises, Incentive Spirometry and Standard Postoperative Care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 4 sitesIraq
- Study dates
- 7 Dec 2025to 7 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq4 sites, 4 recruiting
- Recruiting
Ibn Al-Bitar Specialized Hospital for Cardiac Surgery
Baghdad, Baghdad Governorate
rusul khalid khadim, 96407702612183, asokhalid1234@gmail.com
rusul, asokhalid1234@gmail.com
- Recruiting
Ibn Al-Nafis Hospital for Cardiac, Thoracic and Vascular Surgery
Baghdad, Baghdad Governorate
rusul khalid khadim, 96407702612183, asokhalid1234@gmail.com
rusul, asokhalid1234@gmail.com
- Recruiting
Iraqi Center for Heart Diseases
Baghdad, Baghdad Governorate
rusul khalid khadim, 96407702612183, asokhalid1234@gmail.com
rusul, asokhalid1234@gmail.com
- Recruiting
Imam Al-Hassan Al-Mujtaba Hospital
Karbala, Karbala Governorate
rusul khalid khadim, 96407702612183, asokhalid1234@gmail.com
rusul, asokhalid1234@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease (CHD), Postoperative Respiratory Dysfunction, Postoperative Recovery After Cardiac Surgery
- Being tested
- Coughing Exercises, Incentive Spirometry, Standard Postoperative Care
- Keywords
- Coughing Exercises, Incentive Spirometry, Congenital Heart Disease, Respiratory Function, Recovery, cardiac surgery, pediatric
- Medical subject headings
- Heart Defects, Congenital, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coughing ExercisesBehavioural
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.
Incentive SpirometryDevice
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.
Standard Postoperative CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Coughing Exercises | Experimental | 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. Receives: Behavioral: Coughing Exercises |
| Incentive Spirometry (IS) | Experimental | 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. Receives: Device: Incentive Spirometry |
| Standard Postoperative Care | Active comparator | 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. Receives: Other: Standard Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Score.
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.
Measured: Baseline, 1 hour after intervention, 3 hours, 6 hours, 24 hours, 48 hours, and 72 hours.
Secondary outcomes (4)
Postoperative Recovery Indicators Assessed by Clinical and Functional Parameters
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.
Measured: Baseline, postoperative day 1, and postoperative day 7
Length of Intensive Care Unit (ICU) Stay
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..
Measured: From ICU admission after surgery until ICU discharge, up to postoperative day 14
Arterial Blood Gas (ABG) Parameters
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.
Measured: Baseline (prior to intervention) and 24, and 48 hours after intervention
postoperative complications
Assessment of postoperative complications among pediatric patients following cardiac surgery, including atelectasis, pneumonia, pleural effusion, pneumothorax, respiratory distress, and others during the postoperative period.
Measured: From the first postoperative day until hospital discharge (up to 7 postoperative days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start7 Dec 2025
- Primary completion7 Aug 2026 (estimated)
- Study completion7 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rusul Khalid Kadim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405333
- Sponsor's protocol ID
- UOB-NUR-2026-01
- Acronym
- CEXIS
- Status last verified
- May 2026
- First submitted
- 22 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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..
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Outcomes and Postoperative Recovery Among Children Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT07405333
- Acronym / sponsor ID
- CEXIS / UOB-NUR-2026-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 7 Aug 2026 (estimated)
- Study completion
- 7 Oct 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Coughing Exercises | Experimental | Behavioral: Coughing Exercisesparticipants 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. |
| Incentive Spirometry (IS) | Experimental | Device: Incentive SpirometryParticipants 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. |
| Standard Postoperative Care | Active comparator | Other: Standard Postoperative CareParticipants 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coughing Exercisesparticipants 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. | Behavioural | Coughing Exercises |
| Incentive Spirometryparticipants 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. | Device | Incentive Spirometry (IS) |
| Standard Postoperative CareParticipants 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. | Other | Standard Postoperative Care |
Primary outcome
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.
4 secondary outcomes
Postoperative Recovery Indicators Assessed by Clinical and Functional Parameters
Time frame: 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
Arterial Blood Gas (ABG) Parameters
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. 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..
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coughing Exercises, Incentive Spirometry and Standard Postoperative Care in people with Congenital Heart Disease (CHD) and Postoperative Respiratory Dysfunction, run by University of Baghdad at 4 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rusul khalid khadim, MSc (96407702612183, rusal.khaled1606a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Score. (time frame: Baseline, 1 hour after intervention, 3 hours, 6 hours, 24 hours, 48 hours, and 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.