Respiratory Distress Syndrome, AdultPhase 2NCT00399581
Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome
A Phase 2 study testing High Frequency Oscillatory Ventilation-Hi and High Frequency Oscillatory Ventilation-Lo in people with Respiratory Distress Syndrome, Adult, run by Johns Hopkins University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- High Frequency Oscillatory Ventilation-Hi and High Frequency Oscillatory Ventilation-Lo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute onset of all of the following criteria within a 24-hour period:
- Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
- Requires positive pressure ventilation through an endotracheal tube
- 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
- No clinical evidence of left atrial hypertension
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Maryland Medical Center
Baltimore, Maryland
Ohio State University Medical Center
Columbus, Ohio
Wilford Hall Medical Center
San Antonio, Texas
About this study
Official title: Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- High Frequency Oscillatory Ventilation-Hi, High Frequency Oscillatory Ventilation-Lo
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Mechanical Ventilation, Lung
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Oscillatory Ventilation-HiProcedure or surgery
HFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's.
High Frequency Oscillatory Ventilation-LoProcedure or surgery
HFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's.
| Study group | Role | What they receive |
|---|---|---|
| HFOV-Lo | Experimental | High Frequency Oscillatory Ventilation using lower mean airway pressures and higher FiO2s. Receives: Procedure: High Frequency Oscillatory Ventilation-Lo |
| HFOV-Hi | Experimental | High Frequency Oscillatory Ventilation using higher mean airway pressures Receives: Procedure: High Frequency Oscillatory Ventilation-Hi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator free days
Measured: Measured at 28 days
Changes in plasma concentration of IL-6
Measured: Measured at 3 days
Secondary outcomes (8)
Number of intensive care unit free days
Measured: Measured at 28 days
Mortality
Measured: Measured at 60 days
Number of hospital free days
Measured: Measured at 60 days
Changes in plasma IL1ra
Measured: Measured at 3 days
Changes in plasma IL-1
Measured: Measured at 3 days
Changes in plasma IL-10
Measured: Measured at 3 days
Changes in plasma surfactant protein D
Measured: Measured at 3 days
Changes in plasma von Willebrand factor
Measured: Measured at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Roy G. Brower, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399581
- Sponsor's protocol ID
- 471
- Other IDs
- P50HL073994
- Status last verified
- Jul 2009
- First submitted
- 14 Nov 2006
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1056/NEJMoa050333.
PubMed 16236739Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Krishnan JA, Brower RG. High-frequency ventilation for acute lung injury and ARDS. Chest. 2000 Sep;118(3):795-807. doi: 10.1378/chest.118.3.795.
PubMed 10988205Derdak 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. doi: 10.1164/rccm.2108052.
PubMed 12231488Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. HiFO Study Group. J Pediatr. 1993 Apr;122(4):609-19. doi: 10.1016/s0022-3476(05)83548-6.
PubMed 8463913
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00399581
- Acronym / sponsor ID
- 471
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Mechanical Ventilation, Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFOV-Lo | Experimental | Procedure: High Frequency Oscillatory Ventilation-LoHigh Frequency Oscillatory Ventilation using lower mean airway pressures and higher FiO2s. |
| HFOV-Hi | Experimental | Procedure: High Frequency Oscillatory Ventilation-HiHigh Frequency Oscillatory Ventilation using higher mean airway pressures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute onset of all of the following criteria within a 24-hour period:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Oscillatory Ventilation-HiHFOV will be conducted with recruitment maneuvers and with a table of mPaw and FiO2s that include higher mPaw's. | Procedure or surgery | HFOV-Hi |
| High Frequency Oscillatory Ventilation-LoHFOV will be conducted without routine recruitment maneuvers and with a table of mPaw and FiO2s that include relatively low mPaw's. | Procedure or surgery | HFOV-Lo |
Primary outcome
Number of ventilator free days
Time frame: Measured at 28 days
Changes in plasma concentration of IL-6
Time frame: Measured at 3 days
8 secondary outcomes
Number of intensive care unit free days
Time frame: Measured at 28 days
Mortality
Time frame: Measured at 60 days
Number of hospital free days
Time frame: Measured at 60 days
Changes in plasma IL1ra
Time frame: Measured at 3 days
Changes in plasma IL-1
Time frame: Measured at 3 days
Changes in plasma IL-10
Time frame: Measured at 3 days
Changes in plasma surfactant protein D
Time frame: Measured at 3 days
Changes in plasma von Willebrand factor
Time frame: Measured at 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Background: PubMed 16236739Rubenfeld 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. doi: 10.1056/NEJMoa050333.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 10988205Krishnan JA, Brower RG. High-frequency ventilation for acute lung injury and ARDS. Chest. 2000 Sep;118(3):795-807. doi: 10.1378/chest.118.3.795.
- Background: PubMed 12231488Derdak 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. doi: 10.1164/rccm.2108052.
- Background: PubMed 8463913Randomized study of high-frequency oscillatory ventilation in infants with severe respiratory distress syndrome. HiFO Study Group. J Pediatr. 1993 Apr;122(4):609-19. doi: 10.1016/s0022-3476(05)83548-6.
Related trials for Respiratory Distress Syndrome, Adult
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy G. Brower, MD principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Frequency Oscillatory Ventilation-Hi and High Frequency Oscillatory Ventilation-Lo in people with Respiratory Distress Syndrome, Adult, run by Johns Hopkins University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ventilator free days (time frame: Measured at 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00399581, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.