Measurement of the Metabolic Cost of Inspiratory Muscle Training and Physical Rehabilitation in Mechanically Ventilated Patients; a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
Mechanical ventilation is a life-saving intervention used worldwide. Despite this, critically ill patients who undergo mechanical ventilation commonly develop muscle weakness; this includes limb muscle weakness and diaphragmatic weakness.
Physiotherapy interventions on critically ill patients include; mobilisation to improve limb muscle strength and function, and inspiratory muscle training which aims to target the diaphragm and accessory inspiratory muscles with the goal of improving endurance and strength. Whilst these interventions are standard practice in intensive care, little is known about the physiological load imposed on patients.
The purpose of this study is to assess the feasibility of using indirect calorimetry (measured using the Beacon Caresystem) to measure the metabolic cost (oxygen consumption [VO2] and carbon dioxide production [VCO2]) of inspiratory muscle training and physical rehabilitation in mechanically ventilated intensive care patients.
详细描述
This is an initial cross-sectional study using a non-randomised convenience sample. Patients will be studied during either rehabilitation or Inspiratory Muscle Training.
All participants will have Maximal Inspiratory Pressure (PImax) measured every 5 days. Baseline measurements of VO2 and VCO2 at rest on their baseline ventilation will be measured using the Beacon Caresystem for 1 hour before Inspiratory Muscle Training or physical rehabilitation is initiated.
Inspiratory muscle training will will performed using a resistive device (Philips Respironics ® Threshold PEP device) which is inserted into the participants ventilator tubing 30 minutes before starting inspiratory muscle training. At this point, the device will be set to its lowest setting; the resistance will be overcome by support delivered through the ventilator meaning no additional effort for the participant.
The patient will then perform 12 breaths of inspiratory muscle training at 4cmH20, and at 30%, 50% and 80% PImax with a 30 second rest every 6 breaths and a 10-20 minute rest every 12 breaths
Inspiratory muscle training will normally occur five days per a week. The Beacon Caresystem will be connected for analysis up to 2 days per week.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- •Patient invasively ventilated for ≥ 72 hours
- •Have an endotracheal tube or tracheostomy in situ
- •Respiratory rate of ≤ 35 breaths/min
- •Fraction Inspired Oxygen (Fi02) ≤ 0.50
- •Co-operative and able to participate in physical rehabilitation and inspiratory muscle training
- •Age ≥ 18 years
- •Patient consent or, in the case that the patient is unable, advice from the next of kin and acceptance of oral and written information describing the study.
排除标准
- •Undrained pneumothorax/pneumomediastinum
- •The absence of an arterial catheter for blood sampling at study start
- •Unlikely to survive
- •Pregnancy
- •Consultant discretion that patient is not appropriate
结局指标
主要结局
Recruitment
时间窗: Through study completion, 9 months
The number of patients recruited to the trial compared to the number of eligible patients within the recruitment window
Adherence to IMT
时间窗: Throughout the trial period of each participant whilst enrolled i study
The adherence to the prescribed IMT protocol, including reasons for non-adherence
Prevalence of technical issues with relation to the Beacon Caresystem
时间窗: Through study completion, 9 months
Defined as inability to calibrate before intervention, missing data during interventions, inability to analyse data from interventions.
次要结局
- Assessment of VO2 and VCO2 in ICU patients at rest(60 minutes before physical rehabilitation or inspiratory muscle training)
- Prevalence of low PImax in patients receiving mechanical ventilation and PImax change during course of their admission(Day 0 (baseline) and every 5 days whilst the participant is enrolled in the study)
- Comparison of VO2 and VCO2 during IMT at different percentages of PImax within and between patients(During inspiratory muscle training and for 30 minutes after inspiratory muscle training has ceased)
- Comparison of VO2 and VCO2 during physical rehabilitation in patients receiving mechanical ventilation(During physical rehabilitation and for 30 minutes after physical rehabilitation has ceased)