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NCT00830284 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury
A NA study of Acute Respiratory Distress Syndrome and Acute Lung Injury, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00830284: Completed NA study of Acute Respiratory Distress Syndrome and Acute Lung Injury, sponsored by Boston Children's Hospital.
NCT00830284 is a NA study of Acute Respiratory Distress Syndrome and Acute Lung Injury that has completed, run by Boston Children's Hospital. The registered enrollment target is 12 participants, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830284, a NA study of Acute Respiratory Distress Syndrome and Acute Lung Injury, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
PaO2 + PaCO2 of 400 or higher.
Conditions Studied
Interventions
- PROCEDURE Recruitment maneuver
Study Locations (1)
Massachusetts
- Children's Hospital Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT00830284 record still lists
NCT00830284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Recruitment maneuver is the first listed.
NCT00830284 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00830284 about?
NCT00830284 is a clinical study titled "Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury". 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 ...
What is the current status of trial NCT00830284?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2008-11. Estimated completion is 2012-12.
What conditions does trial NCT00830284 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Acute Lung Injury.
What interventions are being tested in trial NCT00830284?
The interventions under investigation include: Recruitment maneuver (PROCEDURE).
Who is sponsoring clinical trial NCT00830284?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00830284 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00830284's enrollment target sits among peer trials
12 28th of 31 higher than 4 of 31 other Acute Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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