Respiratory Distress Syndrome, AdultPhase 2/3NCT00308022
Comparison Study of High Frequency Percussive Ventilation With Conventional Ventilation
A Phase 2/3 study testing High Frequency Percussive Ventilation in people with Respiratory Distress Syndrome, Adult and Pneumonia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is designed to exam the effects of early management with high frequency percussive ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will be managed with HFPV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Pneumonia, Mechanical Ventilation
- What is being tested?
- High Frequency Percussive Ventilation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to 31 Dec 2009
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PaO2/FiO2 < 300 for less than 24 hours (Ratio of Partial pressure of oxygen to Fraction of inspired oxygen)
Who cannot join
- Documented Pneumonia,
- Documented Congestive Heart Failure,
- Immunosuppression,
- Enrolled in other interventional trial,
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75235
About this study
Official title: A Prospective Randomized Controlled Trial Comparing High Frequency Percussive Ventilation With Conventional Mechanical Ventilation Utilizing Protective Lung Strategies in Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome
This study is designed to exam the effects of early management with high frequency percussive ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will be managed with HFPV. The second group will be managed with conventional ventilation utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator associated pneumonia. We hypothesized that use of HFPV in patients at risk for the development of ARDS will decrease the rate of ventilator associated pneumonia when compared to patients managed with conventional ventilation.
Read the detailed description
Specific Aim 1: This prospective randomized trial will enroll 180 patients with ALI/ARDS over a forty-eight month period. One cohort will receive conventional mechanical ventilation adhering to our well defined protocol of protective lung strategies. A second cohort will have these same strategies applied utilizing the VDR/HFPV. Out come measures will include; ICU/Hospital length of stay, pulmonary infectious complications, airway pressure related complications, PaO2/PaCO2 levels, hemodynamic profiles, and ventilators days.
We hypothesize that patients with Acute Lung Injury (ALI )and/or Acute Respiratory Distress Syndrome (ARDS) managed primarily with HFPV will have fewer ventilators days, fewer infectious complications, and shorter ICU/hospital lengths of stay than patients managed with conventional mechanical ventilation techniques, while maintaining similar oxygenation (PaO2), ventilation (PaCO2), metabolic (pH), and hemodynamic (cardiac output) parameters.
ARDS and ALI have been shown to cause elevations in circulating inflammatory mediators as well as local (alveolar) mediators. The presence of increased amounts of both circulating and alveolar cytokines (inflammatory mediators) has been associated with increased mortality in patients with ARDS/ALI. The pulmonary capillary bed is a rich source of these inflammatory cytokines and the effects of ventilator strategies on circulating and compartmentalized (alveolar) cytokine levels may affect outcome.
Specific Aim 2: Circulating and alveolar inflammatory mediators (IL-6, IL-1-beta, IL-10, and TNF-alpha) will be measured, and activation of other markers of increased synthesis of inflammatory mediators (NF-kappa B and p38 map kinase) will be determined in isolated peripheral blood and alveolar leukocytes.
We hypothesize that patients with ALI/ARDS managed with HFPV will have lower levels of circulating and alveolar pro-inflammatory cytokines (IL-6, IL-1-beta and TNF-alpha) as well as less activation of NF-kappa B and p38 MAP kinase from peripheral blood and alveolar leukocytes.
- Being tested
- High Frequency Percussive Ventilation
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, High Frequency Percussive Ventilation, Ventilator Associated Pneumonia
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Acute Lung Injury, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Percussive VentilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Associated Pneumonia
Measured: 28 days
Secondary outcomes (3)
Cytokine profiles
Measured: 96 hours
Length of stay
Measured: 28 dyas
Ventilator Days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2009 (estimated)
- Study completion31 Dec 2009
Why it stopped: The PI is no longer with the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Randall Friese, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308022
- Sponsor's protocol ID
- UTSW IRB 022005-052
- Status last verified
- Jan 2019
- First submitted
- 24 Mar 2006
- Last updated
- 17 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing High Frequency Percussive Ventilation With Conventional Mechanical Ventilation Utilizing Protective Lung Strategies in Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00308022
- Acronym / sponsor ID
- UTSW IRB 022005-052
- Keywords
- Acute Lung Injury, Acute Respiratory Distress Syndrome, High Frequency Percussive Ventilation, Ventilator Associated Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is no longer with the University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 28 Mar 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.
This study is designed to exam the effects of early management with high frequency percussive ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will be managed with HFPV. The second group will be managed with conventional ventilation utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator associated pneumonia. We hypothesized that use of HFPV in patients at risk for the development of ARDS will decrease the rate of ventilator associated pneumonia when compared to patients managed with conventional ventilation.
Detailed description
Specific Aim 1: This prospective randomized trial will enroll 180 patients with ALI/ARDS over a forty-eight month period. One cohort will receive conventional mechanical ventilation adhering to our well defined protocol of protective lung strategies. A second cohort will have these same strategies applied utilizing the VDR/HFPV. Out come measures will include; ICU/Hospital length of stay, pulmonary infectious complications, airway pressure related complications, PaO2/PaCO2 levels, hemodynamic profiles, and ventilators days.
We hypothesize that patients with Acute Lung Injury (ALI )and/or Acute Respiratory Distress Syndrome (ARDS) managed primarily with HFPV will have fewer ventilators days, fewer infectious complications, and shorter ICU/hospital lengths of stay than patients managed with conventional mechanical ventilation techniques, while maintaining similar oxygenation (PaO2), ventilation (PaCO2), metabolic (pH), and hemodynamic (cardiac output) parameters.
ARDS and ALI have been shown to cause elevations in circulating inflammatory mediators as well as local (alveolar) mediators. The presence of increased amounts of both circulating and alveolar cytokines (inflammatory mediators) has been associated with increased mortality in patients with ARDS/ALI. The pulmonary capillary bed is a rich source of these inflammatory cytokines and the effects of ventilator strategies on circulating and compartmentalized (alveolar) cytokine levels may affect outcome.
Specific Aim 2: Circulating and alveolar inflammatory mediators (IL-6, IL-1-beta, IL-10, and TNF-alpha) will be measured, and activation of other markers of increased synthesis of inflammatory mediators (NF-kappa B and p38 map kinase) will be determined in isolated peripheral blood and alveolar leukocytes.
We hypothesize that patients with ALI/ARDS managed with HFPV will have lower levels of circulating and alveolar pro-inflammatory cytokines (IL-6, IL-1-beta and TNF-alpha) as well as less activation of NF-kappa B and p38 MAP kinase from peripheral blood and alveolar leukocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PaO2/FiO2 < 300 for less than 24 hours (Ratio of Partial pressure of oxygen to Fraction of inspired oxygen)
Key exclusion criteria (4 listed)
- Documented Pneumonia,
- Documented Congestive Heart Failure,
- Immunosuppression,
- Enrolled in other interventional trial,
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 Percussive Ventilation | Device | – |
Primary outcome
Ventilator Associated Pneumonia
Time frame: 28 days
3 secondary outcomes
Cytokine profiles
Time frame: 96 hours
Length of stay
Time frame: 28 dyas
Ventilator Days
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
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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.
Randall Friese, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High Frequency Percussive Ventilation in people with Respiratory Distress Syndrome, Adult and Pneumonia, run by University of Texas Southwestern Medical Center at 1 site 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Ventilator Associated Pneumonia (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019.