Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Quality of life at home
研究概览
简要总结
Air is normally pumped in and out of the lungs by the muscles that contribute to inhalation and exhalation, called the respiratory muscles. The abdominal muscles help by forcing air out of your lungs during exhalation; whereas the diaphragm, the main muscle used for breathing, contracts to get air into the lungs during inhalation. With mechanical ventilation, respiratory muscles are able to rest and recover while the breathing machine takes over; however, this may cause respiratory muscle weakness. Patients who develop weakness of these muscles may require more assistance from the ventilator and take longer to recover their ability to breathe without assistance. The impact of this phenomenon on long-term outcomes is uncertain.
The RESPIRE study is designed to characterize how respiratory muscles change during mechanical ventilation and to evaluate the impact on long term quality of life. An additional objective of this study is to examine novel measures obtained from automated functions of a ventilator, that may better predict success from weaning from mechanical ventilation.
详细描述
Previous work has established that diaphragm atrophy during mechanical ventilation is associated with adverse clinical outcomes. Abdominal muscles, which are engaged during breathing also undergo atrophy during mechanical ventilation. However, the relationship between these muscles and how they relate to long term function status is known and warrants further investigation.
Mechanical ventilation is a life-saving technique in patients with respiratory failure, however reasons why some patients require long term ventilation and are unsuccessful from weaning from ventilators are not fully elucidated. Respiratory muscle dysfunction as a result of mechanical ventilation is only recently being understood. Diaphragm atrophy is associated with adverse clinical outcomes, but the same is unknown if this holds true with abdominal muscle atrophy. Properly understanding the natural progression of diaphragm and abdominal muscle atrophy and dysfunction, and how they relate to each other, is critical to identifying markers or factors that may put particular patients at risk for long durations of mechanical ventilation and adverse clinical outcomes.
This study will provide important insights into the relationship between inspiratory and expiratory muscle function, and the evolution of functional impairments in critical care patients undergoing weaning from invasive mechanical ventilation. Further understanding of the pathophysiological processes of how these muscle groups interact in this context is important in moving forward with potential therapeutic strategies aimed at mitigating injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation
- •Control condition A Inclusion Criteria:
- •Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation
- •Control condition B Inclusion Criteria
- •Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula
排除标准
- •Patients expected to be extubated within 24 hours of screening for eligibility
- •Patients who have already undergone a SBT at time of screening
- •Patients with a previously diagnosed neuromuscular disorder
- •Patients receiving long-term invasive mechanical ventilation (prior to current hospitalization)
- •Patients who have required previously (during current hospitalization) a period of invasive ventilation in ICU of more than 24 hours
- •Patients who have previously been enrolled in the study
- •Patients for whom post-hospital follow-up may be challenging, e.g. those who reside overseas or who have no fixed address
结局指标
主要结局
Quality of life at home
时间窗: Day 180
Montreal Cognitive Assessment (MOCA) score - MoCA is a clinician-reported measure to assess for cognitive impairments. MoCA is scored out of 30 with scores \<26 indicating cognitive impairment.
次要结局
- Muscle research council score(Until day 14)
- Duration of ventilation(Until hospital discharge (up to 6 months))
- Airway occlusion pressure (P0.1)(First spontaneous breathing trial (within 5 minutes of onset))
- Expiratory occlusion pressure (Pocc)(First spontaneous breathing trial (within 5 minutes of onset))
- Maximal inspiratory pressure (MIP)(First spontaneous breathing trial within 30 minutes of onset)
- Days alive and at home at 180 days post ICU discharge(Day 180)
- Changes in abdominal muscle thickening fraction during cough(At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days)
- Maximal diaphragm thickening fraction(At first spontaneous breathing trial within 30 minutes of onset and at ICU discharge, an average of 7 days)
- Changes in resting abdominal muscle thickening(Until Day 14)
- Changes in resting thickening fraction(Until Day 14)