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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830284
First Posted: January 27, 2009
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Walsh, Boston Children's Hospital
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome Acute Lung Injury Procedure: Recruitment maneuver

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury

Resource links provided by NLM:


Further study details as provided by Brian Walsh, Boston Children's Hospital:

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

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

Enrollment: 12
Study Start Date: November 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recruitment
Patients with hypoxic respiratory failure
Procedure: Recruitment maneuver

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.
Other Names:
  • PV maneuver + 2 cmH2O
  • 40 cmH2O for 40 seconds
  • PEEP titration until P400

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All intubated and mechanically ventilated patients on the Medical-Surgical Intensive Care Unit will be screened for the following inclusion criteria:

  1. Age: 44 weeks post conceptual age to 18 years
  2. Acute Lung Injury (ALI): American European Consensus Committee definition of ALI

    1. PaO2/FiO2<300 on ABG within past 6 hours,
    2. Acute onset of bilateral infiltrates on chest radiograph, and
    3. No evidence of left atrial hypertension
  3. Sedation: Must be receiving neuromuscular blockade or demonstrating apnea due to sedation
  4. Arterial line must be present
  5. Conventional mechanical ventilation
  6. Current PEEP levels between 5 and 15 cm H2O

Exclusion Criteria:

  1. Meets the above criteria for ALI for > 72 hours
  2. Active hemodynamic instability
  3. Prematurity (birth at post-conceptual age <37 weeks)
  4. Clinically recognized airways disease (including viral bronchiolitis)
  5. Uncuffed endotracheal tube in place
  6. Congenital heart disease
  7. Hemodynamically significant heart disease
  8. Congenital diaphragmatic hernia
  9. Recent (past 2 months) history of intrathoracic instrumentation (e.g., orthopedic instrumentation, cardiac pacemaker, thoracostomy)
  10. Pulmonary fibrosis
  11. Restrictive lung disease (other than acute lung injury/ARDS)
  12. Cystic fibrosis
  13. Severe pulmonary hypertension
  14. Severe brain injury with no intracranial pressure monitor or external ventricular drain in place
  15. Extra-corporeal life support
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830284


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
  More Information

Responsible Party: Brian Walsh, Research Associate / Research Coordinator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00830284     History of Changes
Other Study ID Numbers: 08-07-0328
Recruitment
First Submitted: December 24, 2008
First Posted: January 27, 2009
Results First Submitted: December 23, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017
Last Verified: December 2016

Keywords provided by Brian Walsh, Boston Children's Hospital:
Pediatric Acute Respiratory Distress Syndrome (ARDS)
Pediatric Acute Lung Injury (ALI)

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries