Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399581
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2006-11-14
Brief Title:
Comparison of Two Methods of High Frequency Oscillatory Ventilation in Individuals With Acute Respiratory Distress Syndrome
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 160000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL073994 | NIH | None | httpsreporternihgovquickSearchP50HL073994 |