CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Recruitment maneuverprocedure
Likely dose
Not stated in record
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Search/NCT00830284
NCT00830284N/ACompleted

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

Boston Children's Hospital·interventional·Posted Jan 27, 2009·Updated Jul 29, 2019

In Brief

A clinical study evaluating Recruitment maneuver for Acute Respiratory Distress Syndrome and Acute Lung Injury. Completed, enrolled 12 participants across 1 site.

Detailed 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 instrumental in defining an optimal strategy for lung recruitment in children with lung injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.4 years ago

Interventions

Recruitment maneuverprocedure

Three types of maneuvers will be performed. 1. 6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level. 2. 6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level. 3. PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher.