机械呼吸机脱机康复计划
综合康复计划与传统胸部理疗的脱机效果
问题陈述:
脱机时(外周肌训练和功能训练)结合吸气肌训练的综合康复方案与传统的胸部理疗(敲击、机械振动、定位和改良体位引流)结合吸气肌训练有什么区别?机械通气作为主要结果,呼吸肌力量、外周肌肉力量和功能状态在困难和长期脱离机械通气时作为次要结果?
这项研究的目的:
本研究的目的是比较综合康复计划结合吸气肌训练与传统胸部物理治疗结合吸气肌训练对脱离机械通气的效果作为主要结果,吸气肌力量,外周肌肉力量,功能状态作为次要结果。
研究概览
地位
条件
详细说明
研究意义 由于医疗技术和跨学科团队合作,危重病人的存活率有所提高。
功能丧失、生活质量和生存率下降以及医疗保健费用增加是 ICU 中长期不动的后果。
欧洲呼吸学会和欧洲重症监护医学学会工作组推荐了基于逐渐增加运动强度的 ICU 动员等级;卧位变化和功能定位、被动移动、主动辅助和主动运动、床上旋转角测量、坐床直立、静态行走、从床上转移到椅子上、椅子运动和步行。
脱机失败可能有不同的病因,如潜在的严重呼吸系统疾病、呼吸肌功能障碍、代谢和内分泌失调以及认知功能障碍。 外周和呼吸肌功能障碍是长期机械通气和 ICU 获得性无力的结果。 应考虑尽早脱离机械呼吸机,以避免因缺乏自主呼吸而引起的并发症和进一步的肌肉萎缩。
有针对性的运动疗法 (TMT) 模拟综合康复计划,将在本研究中使用,是一种管理危重病人的新策略。 这个概念将作为一个科学驱动的、动态的康复干预组合,包括吸气肌力量训练、支气管卫生和主动活动。 这一概念将保证在脱机成功率、使用机械呼吸机的天数、住院时间长短和功能活动能力方面,脱机困难且脱机时间长的危重病人的赌注结果。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cairo Governorate
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Cairo、Cairo Governorate、埃及、62511
- surgical intensive care unit, Kasr Al Ainy Teaching Hospital, Cairo University and Beni- Suef Teaching Hospital , Beni -Suef University.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 一次自主呼吸试验脱机失败的普外科患者
- 清醒的病人
- 血流动力学稳定的患者(无低血压或仅需要低剂量升压药)
- 急性生理学和慢性健康评估 II (APACHE II) 评分 20 或以下的患者
排除标准:
- 持续性感觉改变的患者
- 严重心律失常患者
- 患有合并症(例如神经系统疾病)或服用任何会干扰力量测量和肢体锻炼的镇静剂或麻痹剂的患者
- 有潜在神经肌肉疾病或获得性多发性神经肌病病史的患者
- 由于先前存在的关节功能障碍而无法进行体育锻炼的患者
- 肥胖患者
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Group A (study group)
Forty-five patients will receive a comprehensive rehabilitation programme combined with inspiratory muscle training.
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A threshold inspiratory muscle trainer will be connected to the artificial airway with 15 mm and 22 mm adaptors.
Training bouts consist of three to five sets of six repetitions breathing through the trainer.
Training will be conducted with the patient in bed with an approximately 30° head-up tilt and with intensity about 50 % of maximal inspiratory pressure.
Patients will be returned to mechanical ventilation for rest between training sets as needed.
Three to five sets of six training breaths will be completed for a total of 18 to 30 training breaths per session.
Following each training set, the patient indicated a rating of perceived inspiratory exertion on modified Borg scale .
The study group will also receive comprehensive rehabilitation program consist of upper-extremity exercises, lower extremity exercises, pedaling exercises, trunk control exercises and bedside functional training
其他名称:
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有源比较器:Group B (Control group)
Forty-five patients will receive traditional chest physical therapy combined with inspiratory muscle training.
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研究组采用同样的吸气肌训练结合传统理疗方案,包括体位、改良体位引流、叩击、振动。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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两组成功脱机的百分比
大体时间:最多 30 天或直到拔管
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当急性呼吸衰竭的根本原因稳定或显着改善时,将使用自主呼吸试验,并考虑每天评估患者是否准备好停止呼吸机。
自主呼吸试验将持续 30 分钟至 120 分钟并结合 CPAP,如果试验失败,患者将恢复完全通气支持至少 24 小时,然后再进行新的试验。脱机成功定义为拔管和拔管后 48 小时没有通气支持
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最多 30 天或直到拔管
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inspiratory muscle strength (MIP)
大体时间:at baseline and at immediately before the spontaneous breathing trial
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The mechanical ventilator will be used to measure the plateau pressure (maximal inspiratory pressure).
Plateau pressure was measured using the inspiratory hold function on the venilator while the patient will be sedated and on volume control mode (Sidebotham et al., 2007) The plateau pressure will be measured by ventilator in millibar then it converted to cm o by multiplying it by 1.01971621298 (1millibar equals 1.01971621298 cm 0) and near the figure to the nearest two decimal places
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at baseline and at immediately before the spontaneous breathing trial
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Upper and lower extremity muscle strength
大体时间:at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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Upper and lower extremity muscle strength will be assessed using a handheld dynamometer.
The shoulder flexor, elbow flexor, and knee extensor muscle groups w ill be included in the measurements.
Standard test positions will be modified because all patients in this study are using mechanical ventilator and unable to sit up at initial examination.
The shoulder and elbow flexors will be tested in the semi-Fowler position.
The isometric force of the shoulder flexors will be tested with the shoulder flexed 90 degrees and the elbow in extended position.
The dynamometer will be placed just proximal to the epicondyles of the humerus, and the patients will be stabilized at the axillary region.
The isometric force of the elbow flexors will be tested with the elbow flexed 90 degrees, the forearm supinated, and the shoulder in neutral position; the dynamometer will be placed just proximal to styloid processes of ulna and radius, and the patients will be stabilized at the superior aspect of
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at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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The Functional Independence Measure (FIM)
大体时间:at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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5 activities with The Functional Independence Measure (FIM) were measured, which are bathing, dressing, moving from bed to chair, bowel management, and bladder management.
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at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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Rapid shallow breathing index (RSBI)
大体时间:at baseline and immediately before the spontaneous breathing trial
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The rapid shallow breathing index (RSBI) was determined by dividing the number of breaths per minute (f) by the tidal volume (TV) in liters obtained from a mechanical ventilator
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at baseline and immediately before the spontaneous breathing trial
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Pain level
大体时间:at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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were assessed using a 10 cm visual analog scale (VAS).
Participants evaluated their pain intensity on a scale from 0 (no pain) to 10 (most severe pain possible).
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at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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days to wean
大体时间:at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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Number of days to weaning
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at baseline and at 30 days maximum or until extubation from mechanical ventilator successfully
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合作者和调查者
调查人员
- 研究主任:Hatem ELMoutaz, Professor、Faculty of Medicine , Beni -Suef University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FMBSUREC/05032019/ELMoutaz
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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