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Airway Pressure Release Ventilation in Acute Lung Injury

NCT00750204 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-05-15

Study results available
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Summary

The purpose of this study is to compare airway pressure release ventilation (APRV) to conventional mechanical ventilation (MV) in patients with acute lung injury (ALI) to determine if APRV can reduce agitation, delirium, and requirements for sedative medications. We will also compare markers of inflammation in the blood and lung to determine if APRV reduces ventilator-induced lung injury (VILI), compared to conventional mechanical ventilation.

The proposed study is a randomized, crossover trial. We plan to enroll 40 patients with ALI and randomize to APRV or conventional MV for 24 hours. After this time the patients will be switched to the alternative mode of ventilation (MV or APRV) for another 24 hours. To assess breathing comfort, at the end of each 24-hour period we will measure the amounts of sedative and analgesic medications used. We will also measure the concentrations of markers of inflammation in the blood and lung as measures of VILI. Finally, throughout the study we will compare the adequacy of gas exchange with APRV compared to conventional MV.

Conditions

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Mechanical Ventilation

Interventions

DEVICE

APRV

APRV Protocol * Set fraction of inspired oxygen (FiO2) at 0.1 higher than the setting on conventional MV currently used * Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). * Respiratory rate (RR) to equal 60-65% of RR on conventional MV. * P high = the inspiratory plateau pressure. Maximum P high = 30 cm H20. * Plow = 5 cm water (H2O). Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of percent body weight (PBW). * If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease P high in increments of 2-4 cm H20 to achieve desired release volumes (minimum P high = 12 cm H20). If release volumes on APRV still remain larger than desired,the participant will be excluded from the study and placed on conventional MV.

DEVICE

Conventional MV

Low tidal-volume mechanical ventilation

Sponsors & Collaborators

Principal Investigators

  • Roy G Brower, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-10-15
Completion
2008-10-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00750204 on ClinicalTrials.gov