Measuring Work-of-Breathing in Mechanically Ventilated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The work of breathing (Campbell Diagram)
研究概览
简要总结
Rationale: The most common approach to weaning infants and children is gradual reduction of ventilatory support ("traditional approach"). Alternatively, another approach to weaning is attempted with alternating periods of complete ventilatory support and graded spontaneous breathing with assistance ("sprinting approach"). Both approaches are used randomly in our unit: the decision to use which approach is dependent upon the preferences of the attending physician as described in many observational single center studies. To date, there is no data comparing the safety and efficacy of the "sprinting" approach with more traditional approaches of weaning in children. Hence, numerous issues remain unanswered, including the work-of-breathing during each approach. For this research proposal, we want to measure the work-of-breathing daily, using the traditional approach (the area under the oesophageal pressure - volume curve) and study its correlation with clinical parameters and EMG activity of the diaphragm and intercostal muscles from the moment that the patient is weaned off the ventilator.
Objective: The primary objective for this study is to compare for each patient of the work-of-breathing during the "sprinting"approach and the "traditional approach.The secondary objectives for this study are to compare the oesophageal pressure rate and (PRP) and pressure time product (PTP), the PaO2/FiO2 ratio, global and regional distribution of tidal volume measured using electrical impedance tomography (EIT), phase distribution of the respiratory inductive plethysmography (RIP) signal and the EMG activity of the diaphragm and intercostal muscles between the "sprinting"and the "traditional" approach..
Study design: This is a prospective exploratory study with invasive measurements in a 20 bed tertiary paediatric intensive care facility at the Beatrix Children's Hospital/University Medical Centre Groningen.
Study population: All mechanically ventilated children aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion. Inclusion criteria include mechanical ventilation for at least 48 hours, weight ≥ 3 kg, sufficient respiratory drive present, deemed eligible for weaning by the attending physician, and stable haemodynamics (defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment). Exclusion criteria include mechanical ventilation less than 48 hours, not eligible for weaning (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 > 0.6 within 6 hours prior to enrolment), unstable haemodynamics (defined by the need for increase in vaso-ative drugs and/or fluid challenges within 6 hours prior to enrolment), leakage around the endotracheal tube > 5%, admitted to the neonatal intensive care unit, preterm birth with gestational age corrected for post-conceptional age less than 40 weeks, congenital or acquired neuromuscular disorders, congenital or acquired central nervous system disorders with depressed respiratory drive, congenital or acquired damage to the phrenic nerve, congenital or acquired paralysis of the diaphragm, use of neuromuscular blockade prior to enrolment, uncorrected congenital heart disorder, and chronic lung disease.
Main study parameters/endpoints: The main study parameter is the level and time course of the patient's work-of-breathing mathematically calculated by the area under the pressure-volume curve Secondary study parameters include the level and time course of the PRP and PTP, level and time course of oxygenation (PaO2/FiO2 ratio), global and regional distribution of tidal volume, phase distribution, EMG activity of the diaphragm and intercostal muscles, heart rate, respiratory rate..
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are a priori no specific benefits for the patients who participate in the study.
详细描述
- INTRODUCTION AND RATIONALE The need for mechanical ventilation for respiratory failure is one the most common indications for children to be admitted to a centralized paediatric intensive care unit (PICU) in the Netherlands. Up to 64% of all admitted children need mechanical ventilation for at least 24 hrs (1,2). Hence mechanical ventilation is a key feature in the management of critically ill children. Nevertheless, numerous issues related to the use of mechanical ventilation in children remain unsolved. Much of the current clinical practice is based upon anecdotal experience and data obtained from studies performed in critically ill adults (3). However, the respiratory system is physiologically different between small babies, children and adults implying that all data obtained from adults cannot be easily extrapolated to children (4). For instance (to name but a few), the elastic properties of the lung increases during childhood contributing to increased lung compliance. Furthermore, over the remainder of childhood the lung continues to grow and mature: at the age of 8 years the alveolar surface is about half of that of an adult. Interalveolar pores develop during pre-school years, whereas broncho-alveolar pores begin to develop at the age of 6 - 8 years. The absence of these collateral pathways places children at risk for the development of atelectasis and resulting ventilation/perfusion inequality. Next to this, the resistance of peripheral airways decreases profoundly with increasing age. However, the resistance in an 8-year old is still four times higher than in an adult. Tidal volume (Vt) is comparable between children and adults (about 5 - 7 ml/kg ideal bodyweight), but functional residual capacitity (FRC) in young children is much smaller than in adults. And finally, chest wall compliance is also profoundly different between young children and adults. The chest wall compliance decreases with increasing age because of ossification of the rib cage and an increase in mucular tone of the intercostal muscles.
Although mechanical ventilation is often life saving, it can be associated with complications such as ventilator-induced lung injury and nosocomial pneumonia as recently nicely summarized by Newth et al (5). Endotracheal tubes (ETT) are uncomfortable for patients and increase the need for sedatives. An ETT in the upper airway can be associated with airway injury, particularly in mobile young patients. Furthermore, positive pressure ventilation may contribute to cardiovascular instability from heart-lung interactions. Therefore, it is important that MV be discontinued as soon as the patient is capable of sustaining spontaneous breathing. However, the experience in adults suggests that premature extubation may also be problematic and result in emergent reintubation with attendant complications, including the potential of catastrophic morbidity. A high mortality rate has been documented in both pediatric and adult patients who have required reintubation after extubation failure. Extubation failure is independently associated with a five-fold increased risk of death in pediatric patients. Consequently, although expeditious weaning and extubation are the goal, premature extubation can be lethal. Over 50% of ventilated PICU patients will have been extubated by 48 hrs after admission, but the rest often require prolonged ventilatory support. Both premature and delayed extubation increases morbidity and mortality as well as costs.
Initiation of weaning and timing of extubation have been largely neglected in the pediatric literature (5). Weaning is the transition from ventilatory support to completely spontaneous breathing, during which time the patient assumes the responsibility for effective gas exchange while positive pressure support is withdrawn. There is no standard method of weaning. Indeed, there is disagreement about when the onset of weaning actually occurs and no validated, objective criteria as to when a patient can be extubated (6-9).
The most common approach to weaning infants and children is gradual reduction of ventilatory support. Weaning with intermittent mandatory ventilation (IMV) or synchronized IMV (SIMV) occurs by reducing the ventilatory rate. With pressure support (PS) ventilation, the inspiratory pressure is initially set to provide the required support and then reduced gradually. PS is often combined with IMV/SIMV during weaning (SIMV-PS). Alternatively, another approach to weaning is attempted with alternating periods of complete ventilatory support and graded spontaneous breathing with assistance. This "sprinting" is performed on the theory that the respiratory muscles can be slowly trained to sustain complete spontaneous breathing. Also, theoretically this "sprinting" allows a better distribution of the tidal volume in the lung. Interestingly, both approaches are used simultaneously: the decision to use either one or both approaches is dependent upon the preferences of the attending physician as described in many observational single center studies.
Importantly, there is no data comparing the "sprinting approach with more traditional approaches of weaning in children with respect to patient work-of-breathing. Work-of-breathing is defined by the physiologic work a patient has to deliver to expand the lungs and the chest wall. It can be assessed by various means:
- Bedside: tachypnoea and the presence of nasal flaring and intercostal and/or interjugular retractions indicate increased work of breathing
- Clinical surrogate parameters: the ratio of the inspiratory time to total breathing cycle time, the oesophageal pressure - rate product (PRP), oesophageal pressure - time product (PTP) and expiratory airway resistance (i.e. the difference in transpulmonary pressure and compliance, divided by flow). These clinical surrogate parameters require the presence of an oeosphageal catheter to measure the pressure. These catheters are routinely present in ventilated patients as they are used for nasogastric tube feeding; modern catheters can also measure the oesophageal pressure (i.e. double function).
- Mathematically: the area under the oesophageal pressure - volume curve. This is the classic and traditional approach to measure work of breathing. Its normal value is within the range of 0.5 - 1.0 J/L. The variable is measured by a commercially available ventilator (AVEA, CareFusion, Yorba Linda, CA, USA). To measure this parameter, an oesophageal catheter is necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Weeks 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion
- •mechanical ventilation for at least 48 hours before the start of weaning
- •weight ≥ 3 kg
- •deemed eligible for weaning by the attending physician, i.e. able to initiate and maintain spontaneous breathing.
- •stable haemodynamics, defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment
排除标准
- •mechanical ventilation less than 48 hours for unplanned admissions before the start of weaning
- •post-operative admission with expected duration of mechanical ventilaton less than 48 hours
- •not eligible for weaning as assessed by the attending physician (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 > 0.6 within 6 hours prior to enrolment)
- •unstable haemodynamics, defined by the need for increase in vaso-active drugs and/or fluid challenges within 6 hours prior to enrolment
- •admitted to the neonatal intensive care unit
- •premature birth with gestational age corrected for post-conceptional age less than 40 weeks
- •congenital or acquired neuromuscular disorders
- •congenital or acquired central nervous system disorders with depressed respiratory drive
- •severe traumatic brain injury (i.e. Glasgow Coma Scale < 8)
- •congenital or acquired damage to the phrenic nerve
- •congenital or acquired paralysis of the diaphragm
- •use of neuromuscular blockade prior to enrolment
- •uncorrected congenital heart disorder
- •chronic lung disease
- •severe pulmonary hypertension
结局指标
主要结局
The work of breathing (Campbell Diagram)
时间窗: 10 minutes
The level and time course of the patient work-of-breathing measured by the area under the pressure-volume curve during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the ventilator.
次要结局
- Pressure-time-product (PTP)(10 minutes)
- Pressure-rate-product (PRP)(10 minutes)
研究者
Martin Kneyber
MD PhD FCCM
University Medical Center Groningen
