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临床试验/NCT00830284
NCT00830284已完成不适用

Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Oxygenation

研究概览

简要总结

Lung units which participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units which do not participate in gas exchange (i.e. the derecruited state), which results in impaired gas exchange and induces an inflammatory cascade. Currently, there is no clinical practice guideline in our intensive care unit regarding lung recruitment strategies for children with lung injury. While many studies have demonstrated efficacy (ability to open the lung) and safety of recruitment maneuvers in adults, no such studies have been performed in children.

The primary purpose of this study is therefore to demonstrate the safety and efficacy of a recruitment protocol designed to maximally recruit collapsed lung in children with acute lung injury. Each study patient will follow a recruitment protocol (see Appendix 2). Two 'controls' will be utilized in this study: baseline ventilation (no recruitment maneuver) and the open lung approach (a sustained inflation followed by increased PEEP). Efficacy will be defined as an improvement in lung volume (as measured by nitrogen washout and electrical impedance tomography), and by an improvement in measured arterial partial pressure of oxygen. Safety will be defined as the incidence of barotrauma and hemodynamic consequences which occur during the protocol.

A secondary purpose of this study will be to further validate electrical impedance tomography (EIT) as a non-invasive tool describing the lung parenchyma by comparing it to an accepted standard method of measuring lung volumes, the multiple breath nitrogen washout technique. Validation of EIT would allow clinicians to have a non-invasive image of a patient's lungs without the risks imposed by radiography.

The information we learn will be instrumental in defining an optimal strategy for lung recruitment in children with lung injury.

详细描述

I. Introduction A. Background Lung units which participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units which do not participate in gas exchange (i.e. the derecruited state), at times resulting in impaired gas exchange. Derecruitment of alveoli may also cause intrapulmonary shunting and worsen lung injury through atelectotrauma7. Outcomes in acute respiratory distress syndrome have improved significantly Is this really true? since clinicians have begun to employ lung protective strategies, including low-tidal volume ventilation and permissive hypercapnea8, 9. However, low-tidal volume ventilation has been recognized to decrease recruited lung volume, a phenomenon which persists despite the aggressive positive end-expiratory pressure (PEEP) strategy employed in ARDSNet studies4. Atelectasis associated with low-tidal volume ventilation is relieved through the use of so-called sign breaths, or recruitment breaths10. Further, the proportion of lung remaining in the derecruited state may contribute to the morbidity and mortality associated with acute respiratory distress syndrome (ARDS)11. In adults, several strategies have been utilized to recruit the lung: sustained inflation (SI) and the maximal recruitment strategy. The so-called open lung approach (OLA) includes an SI followed by the setting of PEEP to the measured lower inflection point of the PV curve. An alternative approach to setting PEEP is a decremental PEEP titration, which includes the sequential lowering of PEEP until a predetermined decrement in PaO2 or SaO2 occurs. Studies which have not included a strategy for maintaining lung recruitment following a recruitment maneuver have all been studied.

The impact of lung recruitment in the long-term course of ARDS is not yet clear. It is clear that lung recruitment is most effective earlier in the course of ALI/ARDS. Grasso et al demonstrated that patients who received a recruitment maneuver on day 1±0.3 of ARDS could be recruited, versus patients recruited on day 7±1. Similarly, Gattinoni et al11 and Crotti et al5 found limited recruitment in patients who were well along in the course of ARDS. Borges et al,6 Tugrul et al,12 and Girgis et al all recruited patients early in the course of ARDS, and each found marked lung recruitment, on average, in all the patients studied. Each of these studied demonstrated an ability to improve oxygen saturations and (sometimes studied) end-expiratory lung volume. While no study has examined the effect of this change on morbidity or mortality, in children hypoxemia is known to be a common cause of morbidity. Importantly in children, treatment of hypoxia often drives escalating ventilator settings, the use of high frequency oscillatory ventilation (HFOV) or the use of extra-corporeal membrane oxygenation (ECMO). Early recruitment in children with ALI/ARDS may prevent the need for escalation of care towards these more invasive, and risk-imposing therapies.

Currently, there are no clinical practice guidelines or standard of care regarding lung recruitment strategies for children with lung injury. To date, no studies have been performed in children documenting the efficacy or safety of any of the strategies utilized in intensive care. The primary aim of this study is to demonstrate the efficacy and safety of sustained inflation and maximal recruitment maneuvers in children with lung injury.

B. Lung Recruitment Maneuvers

  1. Sustained Inflations (SI) Sustained inflations (SI) are commonly utilized in the intensive care unit as a recruitment maneuver. In SI, the patient is given a prolonged positive pressure breath (usually between 30 and 45 cm H2O) lasting between 15 and 40 seconds. Clinically, this maneuver is applied following a derecruitment, such as suctioning, or when the patient exhibits hypoxemia. This strategy is currently employed in the Children's Hospital Boston Medical-Surgical Intensive Care Unit in some patients with lung injury, though there is no published evidence of its safety or efficacy in children. Could we put the 3 SI studies in premature infants that use 20-40 cmH20 followed by CPAP? 1 was a rabbit study. The studies described below regard sustained inflation recruitment maneuvers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All intubated and mechanically ventilated patients on the Medical-Surgical Intensive Care Unit will be screened for the following inclusion criteria:
  • Age: 44 weeks post conceptual age to 18 years
  • Acute Lung Injury (ALI): American European Consensus Committee definition of ALI
  • PaO2/FiO2<300 on ABG within past 6 hours,
  • Acute onset of bilateral infiltrates on chest radiograph, and
  • No evidence of left atrial hypertension
  • Sedation: Must be receiving neuromuscular blockade or demonstrating apnea due to sedation
  • Arterial line must be present
  • Conventional mechanical ventilation
  • Current PEEP levels between 5 and 15 cm H2O

排除标准

  • Meets the above criteria for ALI for > 72 hours
  • Active hemodynamic instability
  • Prematurity (birth at post-conceptual age <37 weeks)
  • Clinically recognized airways disease (including viral bronchiolitis)
  • Uncuffed endotracheal tube in place
  • Congenital heart disease
  • Hemodynamically significant heart disease
  • Congenital diaphragmatic hernia
  • Recent (past 2 months) history of intrathoracic instrumentation (e.g., orthopedic instrumentation, cardiac pacemaker, thoracostomy)
  • Pulmonary fibrosis
  • Restrictive lung disease (other than acute lung injury/ARDS)
  • Cystic fibrosis
  • Severe pulmonary hypertension
  • Severe brain injury with no intracranial pressure monitor or external ventricular drain in place
  • Extra-corporeal life support

研究组 & 干预措施

Recruitment

Experimental

Patients with hypoxic respiratory failure

干预措施: Recruitment maneuver (Procedure)

结局指标

主要结局

Oxygenation

时间窗: 2 hours

PaO2 + PaCO2 of 400 or higher.

次要结局

  • Number of Participants With Ventilator Induced Lung Injury(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Walsh

Research Associate / Research Coordinator

Boston Children's Hospital

研究点 (2)

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