Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399581
• Other study ID #: 471
• Secondary ID: P50HL073994
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2006
• Last updated: February 26, 2013
• Start date: November 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Wilford Hall Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator free days		Measured at 28 days	No
Primary	Changes in plasma concentration of IL-6		Measured at 3 days	No
Secondary	Number of intensive care unit free days		Measured at 28 days	No
Secondary	Mortality		Measured at 60 days	No
Secondary	Number of hospital free days		Measured at 60 days	No
Secondary	Changes in plasma IL1ra		Measured at 3 days	No
Secondary	Changes in plasma IL-1		Measured at 3 days	No
Secondary	Changes in plasma IL-10		Measured at 3 days	No
Secondary	Changes in plasma surfactant protein D		Measured at 3 days	No
Secondary	Changes in plasma von Willebrand factor		Measured at 3 days	No