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Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation

Primary Purpose

Acute Lung Injury, Adult Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-tidal-volume ventilation
APRV
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Acute lung injury (ALI), Adult respiratory distress syndrome (ARDS), Low-tidal-volume strategy, ARDS Net, airway pressure release ventilation (APRV), biomarkers of lung injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > or equal to 18.
  • On mechanical ventilation using a volume-controlled mode.
  • Admitted to Boston Medical Center Surgical, Medical, or Coronary Intensive Care Unit.
  • Meets American-European Consensus Criteria for Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome.
  • Required mechanical ventilator for less than 14 days.
  • Met ARDS or ALI criteria for less than 7 days prior to enrollment.
  • Assent of primary care team

Exclusion Criteria:

  • Do not resuscitate order.
  • Increased intracranial pressure.
  • Pregnancy (urine pregnancy test for all women of child-bearing age).
  • Planned transport out of ICU during planned study protocol.
  • Coagulopathy (INR>2.0 or PTT >50).
  • Severe thrombocytopenia (platelets <20,000).
  • History of obstructive lung disease (asthma and/or COPD).

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

low-tidal-volume ventilation

APRV

Arm Description

Goal tidal volume is 6 cc/kg ideal body weight.

APRV allows spontaneous breathing.

Outcomes

Primary Outcome Measures

The study will be powered to detect a decrease in plasma IL-6 levels (pg/ml) from ARDSNet to APRV

Secondary Outcome Measures

Changes in dose of sedation medications
Riker score
Lung mechanics
Oxygenation with APRV versus ARDSNet

Full Information

First Posted
December 22, 2009
Last Updated
December 16, 2016
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01038531
Brief Title
Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation
Official Title
Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. Current evidence-based care of ALI consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further stretch-induced lung injury exacerbated by the ventilator. However, this strategy has been shown to be associated with increased lung injury in a subset of patients and still is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a different, non-experimental strategy of mechanical ventilation currently in routine clinical use. APRV is a pressure-cycled ventilator mode that allows a patient a greater degree of autonomy in controlling his or her breathing pattern than ARDSNet ventilation. Use of APRV has been associated with better oxygenation, less sedative usage, and less ventilator-associated pneumonia in small studies compared with other ventilator modes. However, debate exists over whether APRV might result in decreased or increased ventilator-associated lung injury when compared with ARDSNet ventilation. We intend to implement a randomized, cross over study looking at biomarkers of lung injury in patients with acute lung injury during ventilation with APRV and using the ARDSNet protocol. Our hypothesis is that airway pressure release ventilation is associated with lower levels of lung injury biomarkers than ARDSNet ventilation.
Detailed Description
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. The current evidence-based care consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further lung injury from overstretch of the lung induced by the ventilator. However, this strategy has been shown to be associated with continued lung injury in some studies and still is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a different, nonexperimental strategy of mechanical ventilation currently in routine clinical use. APRV allows a patient a greater degree of autonomy in controlling his/her breathing while achieving a higher mean airway pressure (at similar plateau pressures) than that typically achieved with ARDSNet. APRV has been associated with less ventilator-associated pneumonia, better oxygenation, and less sedative usage in small studies when compared with other methods of ventilation. However, debate exists over net effects of APRV with regard to ventilator-associated lung injury. Additionally, we recently completed a study showing that APRV was associated with lower ventilator associated pneumonia (VAP) rates, but this benefit did not appear to be mediated by sedation differences. We hypothesized that the VAP benefits might be mediated by greater lung recruitment and possibly less ventilator-induced lung injury with APRV. We propose a randomized, crossover study looking at biomarkers of lung injury in patients with acute lung injury ventilated with APRV and ARDSNet. Our hypothesis is that airway pressure release ventilation is associated with lower levels of lung injury biomarkers than ARDSNet ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Adult Respiratory Distress Syndrome
Keywords
Acute lung injury (ALI), Adult respiratory distress syndrome (ARDS), Low-tidal-volume strategy, ARDS Net, airway pressure release ventilation (APRV), biomarkers of lung injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-tidal-volume ventilation
Arm Type
Active Comparator
Arm Description
Goal tidal volume is 6 cc/kg ideal body weight.
Arm Title
APRV
Arm Type
Experimental
Arm Description
APRV allows spontaneous breathing.
Intervention Type
Other
Intervention Name(s)
low-tidal-volume ventilation
Intervention Description
goal tidal volume of 6 cc/kg ideal body weight
Intervention Type
Other
Intervention Name(s)
APRV
Intervention Description
APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.
Primary Outcome Measure Information:
Title
The study will be powered to detect a decrease in plasma IL-6 levels (pg/ml) from ARDSNet to APRV
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Changes in dose of sedation medications
Time Frame
6 hours
Title
Riker score
Time Frame
6 hours
Title
Lung mechanics
Time Frame
6 hours
Title
Oxygenation with APRV versus ARDSNet
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > or equal to 18. On mechanical ventilation using a volume-controlled mode. Admitted to Boston Medical Center Surgical, Medical, or Coronary Intensive Care Unit. Meets American-European Consensus Criteria for Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome. Required mechanical ventilator for less than 14 days. Met ARDS or ALI criteria for less than 7 days prior to enrollment. Assent of primary care team Exclusion Criteria: Do not resuscitate order. Increased intracranial pressure. Pregnancy (urine pregnancy test for all women of child-bearing age). Planned transport out of ICU during planned study protocol. Coagulopathy (INR>2.0 or PTT >50). Severe thrombocytopenia (platelets <20,000). History of obstructive lung disease (asthma and/or COPD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George O'Connor, MD
Organizational Affiliation
Boston University Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation

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