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

NCT00830284 | Completed Results DMC

• 2 other identifiers: 08-07-0328Recruitment
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Respiratory Distress Syndrome; Acute Lung Injury

Keywords

Pediatric Acute Respiratory Distress Syndrome (ARDS); Pediatric Acute Lung Injury (ALI)

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  PaO2 + PaCO2 of 400 or higher.

  2 hours

Secondary Outcomes (1)

• Number of Participants With Ventilator Induced Lung Injury

  4 hours

Study Arms (1)

Recruitment

EXPERIMENTAL

Patients with hypoxic respiratory failure

Procedure: Recruitment maneuver

Interventions

Recruitment maneuver PROCEDURE

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.

Also known as: PV maneuver + 2 cmH2O, 40 cmH2O for 40 seconds, PEEP titration until P400

Recruitment

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 44 weeks post conceptual age to 18 years
• Acute Lung Injury (ALI): American European Consensus Committee definition of ALI
• PaO2/FiO2\<300 on ABG within past 6 hours,
• Acute onset of bilateral infiltrates on chest radiograph, and
• No evidence of left atrial hypertension
• Sedation: Must be receiving neuromuscular blockade or demonstrating apnea due to sedation
• Arterial line must be present
• Conventional mechanical ventilation
• Current PEEP levels between 5 and 15 cm H2O

You may not qualify if:

• Meets the above criteria for ALI for \> 72 hours
• Active hemodynamic instability
• Prematurity (birth at post-conceptual age \<37 weeks)
• Clinically recognized airways disease (including viral bronchiolitis)
• Uncuffed endotracheal tube in place
• Congenital heart disease
• Hemodynamically significant heart disease
• Congenital diaphragmatic hernia
• Recent (past 2 months) history of intrathoracic instrumentation (e.g., orthopedic instrumentation, cardiac pacemaker, thoracostomy)
• Pulmonary fibrosis
• Restrictive lung disease (other than acute lung injury/ARDS)
• Cystic fibrosis
• Severe pulmonary hypertension
• Severe brain injury with no intracranial pressure monitor or external ventricular drain in place
• Extra-corporeal life support

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Results Point of Contact

• Title: John Kheir
• Organization: Boston Children's Hospital

john.kheir@childrens.harvard.edu

6179194712

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate / Research Coordinator

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: January 27, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 29, 2019
• Results First Posted: February 16, 2017

Record last verified: 2019-06

Locations

US (1)