Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison Study of High Frequency Percussive Ventilation With Conventional Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00308022
First received: March 24, 2006
Last updated: September 8, 2006
Last verified: March 2006
  Purpose

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 Intervention Phase
Respiratory Distress Syndrome, Adult
Pneumonia
Mechanical Ventilation
Device: High Frequency Percussive Ventilation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Ventilator Associated Pneumonia

Secondary Outcome Measures:
  • Cytokine profiles
  • Length of stay
  • Ventilator Days

Estimated Enrollment: 180
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
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..

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308022

Contacts
Contact: Dara McBride, RN (214) 648-7609 dara.mcbride@utsouthwestern.edu

Locations
United States, Texas
Parkland Health and Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Dara McBride, RN    214-648-7609    dara.mcbride@utsouthwestern.edu   
Principal Investigator: Randall Friese, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Randall Friese, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308022     History of Changes
Other Study ID Numbers: UTSW IRB 022005-052
Study First Received: March 24, 2006
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

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:
Acute Lung Injury
Pneumonia
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 19, 2014