Acute Lung Injury Clinical Trial
Official title:
Assessing Respiratory Variability During Mechanical Ventilation in Acute Lung Injury
Verified date | March 2016 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Healthy biological systems are characterized by a normal range of "variability" in organ
function. For example, many studies of heart rate clearly document that loss of the normal
level of intrinsic, beat-to-beat variability in heart rate is associated with poor prognosis
and early death.
Unlike the heart, little is known about patterns of respiratory variability in illness. What
is known is that, like the heart, healthy subjects have a specific range of variability in
breath- to-breath depth and timing. Additionally, in animal models, ventilator strategies
that re-introduce normal variability to the breathing pattern significantly reduce
ventilator-associated lung injury.
Critically ill patients requiring mechanical ventilation offer an opportunity to observe and
analyze respiratory patterns in a completely non-invasive manner. Current mechanical
ventilators produce real-time output of respiratory tracings that can analyzed for
variability.
The investigators propose to non-invasively record these tracings from patients ventilated
in the intensive care units for mathematical variability analysis. The purpose of these
pilot analyses are to: (1) demonstrate the range of respiratory variability present in the
mechanically ve ventilated critically ill and (2) demonstrate the ventilator modality that
delivers or permits the closest approximation to previously described beneficial or normal
levels of variability. Future studies will use this pilot data in order to determine if the
observed patterns of respiratory variability in mechanically ventilated critically ill
subjects have prognostic or therapeutic implications.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > or equal to 18. - Requires mechanical ventilation. - Admitted to surgical, medical, or coronary critical care unit - Triggering ventilator above set rate - Meets American European consensus definition of acute lung injury: PaO2/FiO2 ratio <300 or SaO2/FiO2 ratio<315; bilateral infiltrates on chest x-ray (CXR); no congestive heart failure (CHF). Exclusion Criteria: |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center |
United States,
References Davis JN, Stagg D. Interrelationships of the volume and time components of individual breaths in resting man. J Physiol, 1975; 245:481-98. Goldberger AL. Heartbeats, hormones, and health: Is variability the spice of life? Am J Crit Care Med, 2001; 163: 1289-91.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The degree of variability in tidal volume (measured as % variation about the mean) stratified by ventilator mode. | 1 hour | No | |
Secondary | Alternative measures of variability and complexity for each ventilator mode. | 1 hour | No | |
Secondary | Correlations between clinical parameters such as disease severity, vital signs, sedation levels, and variability. | 1 hour | No |
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