Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00399581

Purpose

Acute respiratory distress syndrome (ARDS) is a severe lung condition that causes respiratory failure. Individuals with ARDS often require the use of an artificial breathing machine, known as a mechanical ventilator. High frequency oscillatory ventilation (HFOV) is a form of mechanical ventilation that pumps small amounts of air into the lungs at a constant high rate. The purpose of this study is to compare the safety and efficacy of two HFOV methods in individuals with ARDS.

Condition	Intervention	Phase
Respiratory Distress Syndrome, Adult	Procedure: High Frequency Oscillatory Ventilation-Hi Procedure: High Frequency Oscillatory Ventilation-Lo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Number of ventilator free days [ Time Frame: Measured at 28 days ] [ Designated as safety issue: No ]
Changes in plasma concentration of IL-6 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of intensive care unit free days [ Time Frame: Measured at 28 days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: Measured at 60 days ] [ Designated as safety issue: No ]
Number of hospital free days [ Time Frame: Measured at 60 days ] [ Designated as safety issue: No ]
Changes in plasma IL1ra [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
Changes in plasma IL-1 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
Changes in plasma IL-10 [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
Changes in plasma surfactant protein D [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]
Changes in plasma von Willebrand factor [ Time Frame: Measured at 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HFOV-Lo: Experimental High Frequency Oscillatory Ventilation using lower mean airway pressures and higher FiO2s.	Procedure: High Frequency Oscillatory Ventilation-Lo HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.
HFOV-Hi: Experimental High Frequency Oscillatory Ventilation using higher mean airway pressures	Procedure: High Frequency Oscillatory Ventilation-Hi HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.

Detailed Description:

ARDS is a serious condition that involves lung inflammation and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. It is often fatal and affects approximately 160,000 individuals each year in the United States. The main form of treatment for ARDS is delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation. However, some methods of mechanical ventilation may cause ventilator-associated lung injury (VALI), a condition that can result from overdistension of the lungs during inspiration or from excessive mechanical forces. VALI can delay or prevent healing from respiratory failure.

HFOV is a mechanical ventilation method that pumps small amounts of air into the lungs at a constant high rate. Because the increments of air are small the likelihood of experiencing overdistension and developing VALI may be reduced. While HFOV is an effective, commonly used ventilation method, there have been no studies that demonstrate the efficacy of HFOV in comparison to the efficacy of conventional mechanical ventilation methods. This study will compare two different HFOV techniques: the HFOV-Hi method, which uses higher airway pressure, and the HFOV-Lo method, which uses lower airway pressure. The purpose of this study is to compare the safety and efficacy of HFOV-Hi, HFOV-Lo, and standard mechanical ventilation methods in individuals with ARDS.

This study will enroll individuals with ARDS at four Baltimore hospitals. Participants will be randomly assigned to receive either HFOV-Hi or HFOV-Lo. All participants will receive their assigned HFOV method for 7 days, until spontaneous breathing occurs, or until death, whichever occurs first. Blood collected at baseline and Days 1 and 3 will be analyzed for markers of inflammation and lung injury. Participants' clinical status will be monitored until they no longer need ventilation and return home, or for up to 60 days while in the hospital. Individuals being treated for ARDS at the participating hospitals who decline to enroll in the study will be asked for permission to monitor their medical progress. These individuals will not take part in any study procedures, but their clinical information will be used for comparison purposes. Additionally, clinical information on other ARDS patients admitted to the hospital over the previous 2 years will be analyzed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute onset of all of the following criteria within a 24-hour period:
1. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
2. Requires positive pressure ventilation through an endotracheal tube
3. PaO2/FiO2 less than 200 while receiving positive end-expiratory pressure (PEEP) at more than 8 cm H2O for at least 4 hours, with a duration of no more than 7 days
4. No clinical evidence of left atrial hypertension

Exclusion Criteria:

Weighs less than 35 kilograms
Receives more than 5 days of mechanical ventilation during current hospitalization
Attending physician declines to give consent for participant to enroll
Patient or surrogate declines or is unable to give consent
Participation in another interventional study for ARDS in the 30 days prior to study entry
Intracranial hypertension
Single lung transplant
Burns over more than 30% of the surface area of the body
Pregnant
Sickle (Hgb SS) or sickle-thal (Hgb SC) hemoglobin
Pre-existing illness with a life expectancy of 6 months or less
Physicians and family are not committed to full support (Exception: An individual will not be excluded if he/she would receive all medical care except for attempts at resuscitation from cardiac arrest)
Severe chronic lung disease
Prior lung resection
More than 72 hours has passed since inclusion criteria were met

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399581

Contacts

Contact: Roy G. Brower, MD	410-955-3467	rbrower@jhmi.edu
Contact: Henry E. Fessler, MD	410-955-3467	hfessler@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Roy G. Brower, MD 410-955-3467 rbrower@jhmi.edu
Contact: Henry E. Fessler, MD 410-955-3467 hfessler@jhmi.edu
Principal Investigator: Roy G. Brower, MD
Sub-Investigator: Henry E. Fessler, MD
Sub-Investigator: David N. Hager, MD
Sub-Investigator: Kimberly Boucher, RN
Johns Hopkins Bayview Medical Center	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jonathan Sevransky, MD 410-550-5145 sevransj@jhmi.edu
Principal Investigator: Jonathan Sevransky, MD
Sub-Investigator: Stacey Murray, RRT
University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States
Contact: Carl B. Shanholtz, MD 410-598-4022 cshanhol@medicine.umaryland.edu
United States, Ohio
Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States
Contact: Scott Aberegg, M.D. 614-247-7707
Contact: James O'Brien, M.D. 614-247-7707
Principal Investigator: Scott Aberegg, M.D.
Principal Investigator: James O'Brien, M.D.
Sub-Investigator: Naeem Ali, M.D.
Sub-Investigator: David Newell, M.D.
United States, Texas
Wilford Hall Medical Center	Recruiting
San Antonio, Texas, United States
Contact: Stephen Derdak, D.O. sderdak@mac.com
Principal Investigator: Stephen Derdak, D.O.

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Roy G. Brower, MD

Johns Hopkins University

More Information

Publications:

Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93.

[No authors listed] Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med. 2000 May 4;342(18):1301-8.

Krishnan JA, Brower RG. High-frequency ventilation for acute lung injury and ARDS. Chest. 2000 Sep;118(3):795-807. Review.

Derdak S, Mehta S, Stewart TE, Smith T, Rogers M, Buchman TG, Carlin B, Lowson S, Granton J; Multicenter Oscillatory Ventilation For Acute Respiratory Distress Syndrome Trial (MOAT) Study Investigators. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults: a randomized, controlled trial. Am J Respir Crit Care Med. 2002 Sep 15;166(6):801-8.

[No authors listed] Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. HiFO Study Group. J Pediatr. 1993 Apr;122(4):609-19.

Responsible Party:	Johns Hopkins University School of Medicine ( Roy Brower, MD, Professor of Medicine )
Study ID Numbers:	471, P50 HL073994
Study First Received:	November 14, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00399581
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Acute Respiratory Distress Syndrome
Acute Lung Injury
Mechanical Ventilation
Lung

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009