Comparison Study of High Frequency Percussive Ventilation With Conventional Ventilation

Phase 2

Withdrawn

• Conditions: Pneumonia; Respiratory Distress Syndrome, Adult; Mechanical Ventilation

• Registration Number: NCT00308022
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-24
• Study First Submitted QC: 2006-03-24
• Study First Posted: 2006-03-28
• Primary Completion: 2009-12
• Study Completion: 2009-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ventilator Associated Pneumonia	28 days

Secondary Outcome Measures

Name	Time	Method
Length of stay	28 dyas
Ventilator Days	28 days
Cytokine profiles	96 hours

Trial Locations

Locations (1)

Parkland Health and Hospital System; 🇺🇸 Dallas, Texas, United States