Acute Lung Injury Ventilator Evaluation (ALIVE)

NCT01901354 | Terminated DMC

• 1 other identifier: 2012-0887
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two ventilator modes in mechanically ventilated patients with acute lung injury. Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI. ALI causes 75,000 deaths in the US each year. Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet, pumps a small amount of air into the patient's lungs and then most of the air is released prior to the next breath. Another mode, called Airway pressure release ventilation (APRV), keeps air in the lungs longer between breaths. Both of these modes are currently used at this hospital. The investigators think APRV may help patients with ALI, but we do not know for sure.

Conditions

Acute Lung Injury; Adult Respiratory Distress Syndrome

Keywords

Acute lung injury (ALI); Adult respiratory distress syndrome (ARDS); Low-tidal-volume strategy; ARDSNet; airway pressure release ventilation (APRV); biomarkers of lung injury

Outcome Measures

Primary Outcomes (1)

• Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6 (IL-6)

  We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6(IL-6), a biomarker that has been shown to correlate with degree of lung inflammation. The study will be powered to detect a decrease in plasma IL-6 levels (pg/mL) from ARDSNet to APRV.

  Baseline, Hour 6, Hour 12

Secondary Outcomes (12)

• Impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1)

  Baseline, Hour 6, Hour 12

• Impact of APRV and ARDSNet ventilator modes upon static lung compliance (L/cmH2O).

  Baseline, Hour 6, Hour 12

• Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8)

  Baseline, Hour 6, Hour 12

• Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a)

  Baseline, Hour 6, Hour 12

• Impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D)

  Baseline, 6 Hours, 12 Hours

Study Arms (2)

Low-tidal-volume ventilation

ACTIVE COMPARATOR

Subjects will be ventilated with a goal tidal volume of 6 cc/kg predicted body weight (PBW), a goal plateau pressure of \<30 cm H2O, and a goal respiratory rate of 6-35 bpm to achieve a goal arterial pH of 7.30 to 7.45. Positive end-expiratory pressure is set as per the ARDSNet Positive end-expiratory pressure table

Other: Low-tidal-volume ventilation

Airway pressure release ventilation (APRV)

ACTIVE COMPARATOR

Airway Pressure Release Ventilation (APRV) is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing throughout the respiratory cycle. Initial settings: Pressure high will be set initially to equal the plateau pressure on baseline ARDSNet settings. Time low will be set to 0.5-0.8 seconds to achieve an end expiratory flow 25-50% of peak expiratory flow, and Time high will be set to obtain a set respiratory rate 60%-70% that of baseline settings. Time high will be adjusted to achieve similar continuous exhaled carbon dioxide levels as baseline ARDSNet settings. Low pressure will be set at \<5 cm H20.

Other: Airway Pressure Release Ventilation (APRV)

Interventions

Low-tidal-volume ventilation OTHER

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

Low-tidal-volume ventilation

Airway Pressure Release Ventilation (APRV) OTHER

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

Airway pressure release ventilation (APRV)

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18
• Admitted to intensive care unit
• Has legally authorized representative (LAR) available to provide informed consent in languages allowed by IRB
• Has required mechanical ventilator for less than 14 days
• Meets all of the following American-European Consensus Criteria for Acute Lung Injury or Acute Respiratory Distress Syndrome: a. Acute onset of respiratory compromise, AND b. Bilateral chest radiographic infiltrates, AND c. PaO2/FiO2 ratio less than 300, OR if no arterial blood gas has been drawn by the clinical care team, a saturation O2/FiO2 ratio less than 315 with an O2 saturation less than 97%), AND d. Known pulmonary wedge pressure less than 18 mmHg, OR if pulmonary wedge pressure is not known, left-sided heart failure is not the most likely explanation for the patient's clinical findings of bilateral infiltrates and/or low PaO2/FiO2 ratio
• Has met ALI criteria for less than 7 days prior to enrollment
• Approval of intensive care unit attending physician
• Has arterial catheter in place
• Meets Clinical Stability Criteria for at least one hour prior to the start of study procedures. Note: Clinical Stability Criteria must be maintained throughout the duration of the intervention period.

You may not qualify if:

• Patient has a Do Not Resuscitate Order
• Evidence of increased intracranial pressure (e.g. presence of intraventricular catheter, brain herniation)
• Patient is pregnant (if pregnancy test was not performed as part of routine clinical care, a urine pregnancy test must be performed for women of childbearing potential after informed consent obtained)
• Planned transport out of ICU during study protocol
• Coagulopathy within the past 48 hours (INR greater than 2.0 or PTT greater than 50 seconds)
• Severe thrombocytopenia within the past 48 hours (platelets less than 20,000 per μL)
• History of obstructive lung disease (asthma and/or COPD)
• Patients who are currently prisoners

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Suresh Agarwal, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: July 17, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

US (1)