Pulmonary Rehabilitation in the Chronically Critically Ill Patient: Prospective Study About Clinical Characteristics and the Response to Rehabilitation in This Patient Population and Search for Potential Predictive Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Modified barthel index (mBI)
研究概览
简要总结
The goal of this observational study is to learn about the population of chronically critical ill patients who refer to respiratory rehabilitation units.
The main questions it aims to answer are:
- what are the clinical and pathophysiological characteristics of the population of chronically critical ill patients who refer to respiratory rehabilitation units after hospital admission with the need for prolonged invasive mechanical ventilation via tracheostomy?
- what is the response of this patient population to respiratory rehabilitation treatment in terms of functional recovery, weaning from invasive mechanical ventilation, weaning from tracheostomy tube, mortality and return to home?
- are there any appreciable indices at admission and/or in the first period of hospitalization which may have a prognostic significance both on short-term objectives (weaning from invasive mechanical ventilation, weaning from the tracheostomy tube) and in the medium-long term (survival, state of health)?
Participants will be subjected to a rehabilitation and weaning program consisting of:
- physical therapy,
- speech therapy,
- nutritional assessment and therapy,
- in subjects on invasive mechanical ventilation at admission a program of weaning and, if needed, shift from invasive to Non-Invasive Ventilation will be performed.
详细描述
Observational, prospective, non-profit study. The first aim is to define the clinical and pathophysiological characteristics of the population of chronic critically ill patients who refer to respiratory rehabilitation units after hospital admission with the need for prolonged invasive mechanical ventilation via tracheostomy.
The second aim is to identify the following aspects: evaluating the response of this particular patient population to respiratory rehabilitation treatment (functional recovery, weaning from invasive mechanical ventilation, decannulation and home discharge), knowing the mortality of this patient population and evaluating the existence of appreciable indices at admission and/or in the first period of hospitalization which may have a prognostic significance both on short-term objectives (weaning from invasive mechanical ventilation, weaning from the tracheostomy tube) and in the medium-long term (survival, state of health). This last aspect could also be useful for the early identification of patients who could benefit from rehabilitation treatment more than others and therefore to optimize the resources at our disposal.
The present study involves the collection of data from chronically critical patients who will be referred to the Rehabilitation Pneumology Unit of the Don Gnocchi Foundation in Florence after hospitalization in intensive care for respiratory failure with the need for prolonged invasive mechanical ventilation.
The prospective analysis will have a total duration of 6 months.
The enrolled patients will follow the standard care path provided by the center and in this context they will carry out the rehabilitation treatment both within the department and in the dedicated respiratory gym.
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
- •age >18 years;
- •episode of acute or acute-on-chronic respiratory failure with the need for prolonged invasive mechanical ventilation via tracheostomy
排除标准
- •condition of clinical instability such as to make it necessary to transfer the patient to acute hospital within the first 7 days of hospitalization.
结局指标
主要结局
Modified barthel index (mBI)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An ordinal scale used to measure a subject's performance in Activities of Daily Living (ADL), with a score from 0 to 100 where higher values correspond to a greater level of autonomy
Hospital Anxiety and Depression Scale (HADS)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A self-reported measure, made up of 14 items, 7 for the evaluation of anxiety and 7 for depression. For both anxiety and depression the score ranges from 0 to 21. The higher scores correspond to a greater probability of being affected by the pathology.
Change in nutritional status from admission to discharge
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Global Leadership Initiative on Malnutrition (GLIM) criteria are 5 diagnostic criteria to assess malnutrition that include 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation /disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
arterial blood gas analysis
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
evaluation of respiratory exchanges in terms mainly of oxygen blood pressure (mmHg) and of carbon dioxide blood pressure (mmHg).
Pain evaluation
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
Intensity of the pain is assessed through the visual analogue scale (VAS). A 10 cm long visual scale where the length corresponds directly to the pain
Number of patients weaned from invasive mechanical ventilation
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
for each patient the need for invasive mechanical ventilation and its possible removal are assessed
functional independence measure (FIM) scale
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An international standard for measuring disability, with a score from 18 to 126 where higher values correspond to a greater level of autonomy
Short Form 12 (SF12)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A self-reported measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure, with a score from 12 to 47 where lower values correspond to a better quality of life.
Number of patients weaned from the tracheostomy tube
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
for each patient the presence of the tracheostomy tube and its possible removal are assessed
Short Physical Performance Battery (SPPB)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A group of measures that combines the results of the gait speed, chair stand and balance tests. It can be useful as a predictive tool for possible disability and can aid in the monitoring of function. With a score from 0 to 12 where higher values correspond to a better motor function.
Barthel dyspnea
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
An ordinal scale used to measure a subject's level of dyspnea while performing Activities of Daily Living (ADL), with a score from 0 to 100 where lower values correspond to a greater level of dyspnea.
Malnutrition Universal Screening Tool (MUST) scale
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A screening tool to identify malnourished adults, at risk of malnutrition (undernutrition) or obesity. It has a score ranging from 0 to 6. The lower score corresponds to a lower risk of malnutrition.
Montreal Cognitive Assessment (MoCA)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The MoCA is a tool for rapid screening of mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The maximum possible score is 30 points; an equal score or above 26 is considered normal.
Functional Oral Intake Scale (FOIS)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
A tool to assess functional oral intake of food and liquids in patients with oropharyngeal dysphagia. The score ranges from 1 (no oral intake) to 7 (total oral intake with no restrictions).
Medical Research Council (MRC) Scale
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The MRC Scale is a scale of 6 values, ranging from 0 to 5, for measuring strength through the observation of muscle movements and behavior for grades from 0 to 3, and the administration of manual muscle tests for grades 4 and 5. It consists of a strength attribution score, ranging from 0 (absence of contraction) to 5 (normal strength).
Modified Rankin Scale (MRS)
时间窗: From date of randomization until the date of discharge or date of hospitalization or death from any cause, whichever came first, assessed up to 1 year .
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of patients. The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
次要结局
未报告次要终点