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临床试验/NCT05522712
NCT05522712Unknown不适用

Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Pulmonary function test

研究概览

简要总结

Valvular heart disease (VHD) is a growing and important public health problem due to the increasing prevalence of degenerative VHD, accompanied by prolonged life expectancy in developed countries. It is associated with high morbidity and mortality.Heart valve surgery is one of the proven treatments of VHD, which corrects hemodynamic abnormalities that could contribute to decrease mortality and improvement in quality of life, despite the improvement in the hemodynamic parameters, the cardiorespiratory fitness level remained low after heart valve surgery.

Cardiac surgeries can cause a series of clinical and functional complication. Postoperative pulmonary complications are the most common, in turn, contribute directly to increase morbidity and mortality and longer hospital stays.Mucociliary clearance is affected after open-heart surgery by the effects of general anaesthesia, intubation and analgesia. Expiratory flow rate is directly related to lung volume and therefore when lung volumes are decreased, coughing will be less effective.

Chest physical therapy plays an important role in the prevention and management of postoperative pulmonary complications. It includes deep breathing exercises, mobilization, postural drainage, percussion and vibration or shaking which were developed to improve bronchial drainage. Airway clearance techniques are commonly used for clearing secretions, improving gas exchange, oxygenation, and work of breathing. Acapella® is an airway clearance device that combines the resistive features of a positive expiratory pressure device with oscillations which diminishes the mucus adhesiveness and decrease the collapsibility of airways.

In the present study, the aim is to compare the effect of acapella and incentive spirometer on cardiopulmonary fitness in patients undergoing heart valve surgery. Those patients may gain a more benefit from acapella application and incentive spirometer so, prevent post-operative pulmonary complication, reduce hospitalization and hospital costs, and improve quality of life. Therefore, early mobilization and chest physiotherapy including acapella and incentive will be started on 1st day after discharge from cardiac care unit (CCU) .

详细描述

This study is designed to compare between effect of acapella and incentive spirometer on cardiopulmonary fitness after heart valve surgery.The patients of this study will randomly assigned into three equal groups in numbers.

Study Group A will receive acapella protocol in addition to traditional chest physiotherapy, early mobilization and sternal precautions.

Study Group B will receive incentive spirometer in addition to traditional chest physiotherapy, early mobilization and sternal precautions.

Control Group C will receive traditional chest physiotherapy, early mobilization and sternal precautions.

The program of treatment for each patient will be applied daily starting from the first day the patient will be extubated (2nd postoperative day) up to 7 days.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with age ranges (30-40) years old.
  • Patients with normal body mass index ranges (18.5-24.9) kg/m2
  • Patients undergo mitral valve surgery via median sternotomy.
  • Post operative, extubated heart valve surgery patients, who were able to follow the instructions and sign the consent form.
  • Patients with hemodynamic stability.
  • Patients with controlled diabetes mellitus.

排除标准

  • - Patients who required more than 48 hours of intubation after surgery.
  • Reintubation in post operative period.
  • Patients who had history of respiratory tract infection within a period of three months.
  • Patients undergo CABG ,or double valve surgery.
  • Patients with any neuromuscular disease.
  • Patients with severe renal dysfunction.
  • Anemic patients.
  • Uncontrolled diabetes mellitus.

结局指标

主要结局

Pulmonary function test

时间窗: 7 days

Forced vital capacity and forced expiratory volume in one second will be measured

Rate of perceived exertion

时间窗: 7 days

Dysnpea level measured by modified borg scale from 0 to 10 0 no dyspnea at all 10 maximal degree of dyspnea

Pain intensity

时间窗: 7 days

Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain

Peripheral oxygen saturation

时间窗: 7 days

Determine level of oxygen in blood

Cardiorespiratory fitness evaluation

时间窗: 7 days

Vo2max is measured to determine functional capacity after operation

Length of hospital stay

时间窗: Average 4 - 7 days

Determine how many days patient need to be in hospital and become fully hemodynamically stable

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samira Abdelrehim Mahmoud shehata

Principal investigator

Cairo University

研究点 (2)

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