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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 instrumen

Detailed Summary:

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
Sponsor: Boston Children’s Hospital

Current Primary Outcome: PaO2 + PaCO2 of 400 or Higher. [ Time Frame: 2 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety - Airleak, Cardiac Compromise, Respiratory Acidosis. [ Time Frame: 4 hours ]

Original Secondary Outcome: Safety - airleak or cardiac compromise. [ Time Frame: 4 hours ]

Information By: Boston Children’s Hospital

Dates:
Date Received: December 24, 2008
Date Started: November 2008
Date Completion:
Last Updated: December 23, 2016
Last Verified: December 2016