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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00830284
First received: December 24, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Lung Recruitment Protocol in Children With Acute Lung Injury

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

Primary Outcome Measures:
  • PaO2 + PaCO2 of 400 or higher. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety - airleak or cardiac compromise. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (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

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
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 ALI40

    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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830284

Contacts
Contact: Brian K Walsh, BS, MBA 617-935-7885 brian.walsh@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Brian K Walsh, BS, MBA, RRT     617-935-7885     brian.walsh@childrens.harvard.edu    
Principal Investigator: John H Arnold, MD            
Sub-Investigator: Gerhard Wolf, MD            
Sub-Investigator: John Kheir, MD            
Sub-Investigator: John Thompson, RRT-NPS            
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: John Arnold, MD Associated Professor, Children's Hospital Boston, Harvard Medical School
ClinicalTrials.gov Identifier: NCT00830284     History of Changes
Other Study ID Numbers: 08-07-0328, Recruitment
Study First Received: December 24, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013