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Comparison Study of High Frequency Percussive Ventilation With Conventional Ventilation

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ClinicalTrials.gov Identifier: NCT00308022
Recruitment Status : Withdrawn (The PI is no longer with the University)
First Posted : March 28, 2006
Last Update Posted : January 17, 2019
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Pneumonia Mechanical Ventilation Device: High Frequency Percussive Ventilation Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Estimated Primary Completion Date : December 2009
Actual Study Completion Date : December 31, 2009





Primary Outcome Measures :
  1. Ventilator Associated Pneumonia [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Cytokine profiles [ Time Frame: 96 hours ]
  2. Length of stay [ Time Frame: 28 dyas ]
  3. Ventilator Days [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PaO2/FiO2 < 300 for less than 24 hours (Ratio of Partial pressure of oxygen to Fraction of inspired oxygen)

Exclusion Criteria:

  • Documented Pneumonia,
  • Documented Congestive Heart Failure,
  • Immunosuppression,
  • Enrolled in other interventional trial,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308022


Locations
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United States, Texas
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Randall Friese, MD University of Texas Southwestern Medical Center
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ClinicalTrials.gov Identifier: NCT00308022    
Other Study ID Numbers: UTSW IRB 022005-052
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by University of Texas Southwestern Medical Center:
Acute Lung Injury
Acute Respiratory Distress Syndrome
High Frequency Percussive Ventilation
Ventilator Associated Pneumonia
Additional relevant MeSH terms:
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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury