Diaphragm Ultrasound Evaluation of the Effects of High Intensity or Low Intensity Inspiratory Muscle Training in Patients With Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in diaphragm excursion measured by diaphragm ultrasound
研究概览
简要总结
Diaphragm dysfunction contributes to prolonged mechanical ventilation (PMV) and difficult weaning. Inspiratory muscle training (IMT) may improve respiratory muscle performance, while serial diaphragm ultrasound offers a bedside method for monitoring diaphragmatic recovery. This study used diaphragm ultrasound to evaluate the effects of high- versus low-intensity IMT in patients with PMV and diaphragm dysfunction.
In this prospective study, patients received high- or low-intensity IMT for up to 2 weeks or until ventilator liberation. Respiratory mechanics, including respiratory rate, tidal volume, minute ventilation, rapid shallow breathing index, and maximal inspiratory pressure, were assessed twice weekly. Diaphragm excursion and thickening fraction were also measured serially after IMT initiation. Changes in respiratory physiological parameters and diaphragm ultrasound measurements were compared between the two IMT groups, and differences in ventilator liberation outcomes were evaluated.
详细描述
Prolonged mechanical ventilation (PMV) is associated with substantial morbidity, mortality, and healthcare resource utilization. In Taiwan, approximately 170,000 patients receive mechanical ventilation annually, of whom an estimated 13%-16% remain ventilator-dependent for more than 21 days and 3.7%-5.6% require ventilatory support for more than 63 days. Diaphragm dysfunction is an important physiological contributor to difficult ventilator liberation. Prolonged mechanical unloading, systemic inflammation, critical illness, and disuse may result in diaphragmatic atrophy, structural injury, and impaired contractility.
Inspiratory muscle training (IMT) is used during ventilator rehabilitation to improve inspiratory muscle strength and endurance. IMT may be delivered using resistive-loading or threshold-loading devices. Threshold-loading devices provide a relatively constant, flow-independent inspiratory resistance and permit training intensity to be prescribed according to maximal inspiratory pressure (Pimax). Similar to peripheral skeletal muscle training, respiratory muscle adaptation is influenced by the magnitude and progression of the applied workload. However, the appropriate training intensity for patients with PMV and diaphragm dysfunction remains uncertain. Higher-intensity training may provide a stronger physiological stimulus but may be less well tolerated, whereas lower-intensity training may be easier to perform but may produce a smaller training response.
The effects of IMT have traditionally been evaluated using global respiratory measurements such as Pimax, tidal volume, respiratory rate, minute ventilation, and the rapid shallow breathing index. Although these measurements provide clinically relevant information, most are effort-dependent and do not directly assess diaphragm-specific mechanical recovery. Point-of-care diaphragm ultrasound provides a noninvasive bedside method for serial evaluation of diaphragmatic function. Diaphragm excursion reflects craniocaudal diaphragmatic displacement during inspiration, while diaphragm thickening fraction reflects inspiratory muscle contraction within the zone of apposition.
This prospective, single-center, randomized controlled trial compared high-intensity and low-intensity inspiratory muscle training (IMT) in adults with prolonged mechanical ventilation and inspiratory muscle weakness who had been transferred from an intensive care unit to a specialized respiratory care center. Eligible participants were randomly assigned to receive an individualized IMT workload based on baseline maximal inspiratory pressure (Pimax). The high-intensity group trained at 50% of baseline Pimax, and the low-intensity group trained at 20% of baseline Pimax.
IMT was administered using a Dofin® adjustable-resistance threshold inspiratory muscle trainer (GaleMed Corporation, Taiwan). During each training session, the device was connected directly to the endotracheal or tracheostomy tube by a respiratory therapist after temporary disconnection from the mechanical ventilator. Each cycle included 6-10 inspiratory efforts, and five cycles were performed daily. Rest periods of 1-3 minutes were provided between cycles to reduce acute respiratory muscle fatigue. Pimax was reassessed twice weekly, and the training resistance was adjusted according to the updated measurement.
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
- 20 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent.
- •Adults aged >20 years.
- •Patients requiring mechanical ventilation for >21 days and admitted to the Respiratory Care Center (RCC).
- •Hemodynamically stable and not receiving vasopressor therapy.
- •Clinically stable and considered by the attending physician to be ready to begin weaning from mechanical ventilation. Ventilator settings must meet all of the following criteria:
- •(1) Fraction of inspired oxygen (FiO₂) < 0.
- •(2) Positive end-expiratory pressure (PEEP) ≤10 cmH₂O. (3) Able to trigger spontaneous breaths on the ventilator. (4) Respiratory rate <25 breaths/min. (5) Respiratory muscle weakness confirmed by maximal inspiratory pressure (MIP), defined as MIP <30 cmH₂O.
排除标准
- •Hemodynamic instability, including cardiac arrhythmia, decompensated heart failure, or acute coronary syndrome.
- •Active hemoptysis.
- •Presence of a chest tube.
- •Use of home mechanical ventilation.
- •Uncontrolled pain or dyspnea.
- •Patients determined to be ventilator-dependent and requiring long-term mechanical ventilation.
- •Patients or their legally authorized representatives who are unwilling or unable to provide written informed consent.
结局指标
主要结局
Changes in diaphragm excursion measured by diaphragm ultrasound
时间窗: From enrollment to the end of study at 2 weeks.
Changes in thickening fraction measured by diaphragm ultrasound
时间窗: From enrollment to the end of study at 2 weeks.
次要结局
- Change in rapid shallow breathing index (RSBI)(From enrollment to the end of study at 2 weeks.)
- Successful ventilator liberation(From enrollment to the end of study at 2 weeks.)
- Change in maximal inspiratory pressure (PImax)(From enrollment to the end of study at 2 weeks.)
- Change in respiratory rate (RR)(From enrollment to the end of study at 2 weeks.)
- Change in tidal volume (VT)(From enrollment to the end of study at 2 weeks.)
- Change in minute ventilation (MV)(From enrollment to the end of study at 2 weeks.)
研究者
MENG-JER HSIEH
Attending Physician of Pulmonary and Critical Care Medicine
Chang Gung Memorial Hospital
