Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Outcomes and Postoperative Recovery Among Children Undergoing Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Respiratory Function Score.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Coughing Exercises (Behavioral)
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.
干预措施: Incentive Spirometry (Device)
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.
干预措施: Standard Postoperative Care (Other)
结局指标
主要结局
Respiratory Function Score.
时间窗: 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.
次要结局
- Arterial Blood Gas (ABG) Parameters(Baseline (prior to intervention) and 24, and 48 hours after intervention)
- Postoperative Recovery Indicators Assessed by Clinical and Functional Parameters(Baseline, postoperative day 1, and postoperative day 7)
- Length of Intensive Care Unit (ICU) Stay(From ICU admission after surgery until ICU discharge, up to postoperative day 14)
研究者
Rusul Khalid Kadim
Graduate Student / Principal Investigator
University of Baghdad