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

NCT01038531 | Terminated DMC

• 1 other identifier: H-28944
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  6 hours

Secondary Outcomes (4)

• Changes in dose of sedation medications

  6 hours

• Riker score

  6 hours

• Lung mechanics

  6 hours

• Oxygenation with APRV versus ARDSNet

  6 hours

Study Arms (2)

low-tidal-volume ventilation

ACTIVE COMPARATOR

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

Other: low-tidal-volume ventilation

APRV

EXPERIMENTAL

APRV allows spontaneous breathing.

Other: APRV

Interventions

low-tidal-volume ventilation OTHER

goal tidal volume of 6 cc/kg ideal body weight

low-tidal-volume ventilation

APRV OTHER

APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.

APRV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• George O'Connor, MD

  Boston University Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: July 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

US (1)