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临床试验/NCT06012474
NCT06012474已完成不适用

Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 50 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
状态
已完成
入组人数
50
试验地点
1
主要终点
Assessing the change in Arterial Blood gases

研究概览

简要总结

The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.

详细描述

No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female patients with valve surgery (valve replacement or repair with median sternotomy procedure).
  • Age between 25 to 35 years old.
  • BMI is between 18.5 to 24.5 kg/m2.

排除标准

  • The participants will be excluded if they meet one of the following criteria:
  • Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
  • Patients with coronary artery disease or heart failure.
  • Need for mechanical ventilation for >24 h or reintubation.
  • Renal and hepatic disorders.
  • Infected or unstable sternum.
  • patient with pneumothorax after surgery.
  • Metabolic disorders.
  • Pregnant woman.
  • Lactating mother.
  • Stroke patient

结局指标

主要结局

Assessing the change in Arterial Blood gases

时间窗: within 24 hours after 1 week of intervention

Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.

Assessing the change in diaphragmatic excursion

时间窗: within 24 hours after 1 week of intervention

By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.

Assessing the change in capacity to perform daily activities

时间窗: within 24 hours after 1 week of intervention

by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).

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

Hend Mahdy Hassan Mohamed

Principal Investigator

Cairo University

研究点 (1)

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