Effects of Respiratory Muscle Training in Mechanically Ventilated Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 主要终点
- Weaning Time From Mechanical Ventilation
研究概览
简要总结
Respiratory muscle training (RMT) is considered a therapeutic strategy to improve respiratory muscle strength in mechanically ventilated (MV) patients and facilitates ventilator weaning. RMT aims at improving strength and endurance of respiratory muscles . However, scarce research exists regarding evaluation of RMT in MV patients and additionally studies differ in methods, RMT protocols and subjects included. There are not reports about Colombian studies evaluating RMT effects on MV patients. The aim of this study is to evaluate the effectiveness of respiratory muscle training in increasing respiratory muscle strength and improving weaning outcomes in MV patients who required ventilatory support for more than 48 hours at an Intensive Care Unit of an IV level Hospital in Cali during the period 2014-2015
详细描述
Patients who have been under mechanical ventilation for 48 hours are invited for participation in this study. Once participants are identified and his/her legal representative has decided to participate through an informed consent, subjects are randomly assigned to the experimental or conventional group.
Data collection begins with registering individual information into a data collection form that has been designed for the study; muscle strength is measured as Maximum Inspiratory Pressure (MIP). Then, patients are assigned either to experimental or group control using opaque sealed envelopes. Stratified randomization is performed, using SEPSIS status as strata, and within each category randomization block size is 4 and 6 respectively. Once sepsis status has been established, green envelopes are opened for patients with sepsis, and blue envelopes are opened for patients without sepsis. Finally intervention is performed according to group assignment.
Interventions
Conventional Therapy Group Control group receives conventional intervention of Cardiopulmonary Physical Therapy which has been established by institutional protocols, and consists of Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
Measuring Respiratory Muscle Strength
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years at least
- •Informed consent to participate in study by legal representative or family member
- •First event requiring mechanical ventilation
- •Being intubated at the study setting ( Valle del Lili Foundation) or at peripheral services and referred 12 hours or less after intubation
- •Adequate gas interchange: Blood pressure of oxygen > 60 mmHg with Inspired fraction of oxygen ≤
- •5 and positive pressure at end of expiration (PEEP) < 8 cmh20
- •Sedation level between -1 and 0 (24, 25)
- •Hemodynamic stability: Medium arterial blood pressure > 60 mmHg without vasopressors or requiring a minimum of vasopressor support (epinephrine < 0,4 mcg/Kg/ min)
排除标准
- •Progressive neuromuscular disease such as Amyotrophic Lateral Sclerosis , Muscular Dystrophy, Multiple Sclerosis, Myasthenia Gravis, or other neuromuscular disorder that could interfere with response to inspiratory muscle training .
- •Central nervous system disorders: severe traumatic brain injury
- •Spinal cord injury at a level higher than T8
- •Chest or spine skeletal disorders (scoliosis, flail chest, spine surgery) that limit movement of ribs and rib cage.
- •Requirement of ventilatory support at home prior to hospitalization
- •Presence of excessive secretions (requiring more than one suctioning procedure every hour).
- •Tracheostomy
- •Previous requirement of mechanical ventilation during this period of hospitalization
- •Pregnancy
研究组 & 干预措施
Respiratory Muscle Training
Experimental group receives as additional treatment respiratory muscle training.
干预措施: Respiratory muscle training (Other)
Respiratory Muscle Training
Experimental group receives as additional treatment respiratory muscle training.
干预措施: Cardiopulmonary Physical Therapy (Other)
Conventional physical therapy
Conventional Cardiopulmonary Physical Therapy
干预措施: Cardiopulmonary Physical Therapy (Other)
结局指标
主要结局
Weaning Time From Mechanical Ventilation
时间窗: Measured by the end of the period of mechanical ventilation, an average expected time of 4 days
Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation
次要结局
- Changes in Maximum Inspiratory Pressure (MIP)(Measured at baseline (baseline MIP) and right before patient extubation (finalMIP, an average of 2 hours))