Clinical Trials Directory

Trials / Completed

CompletedNCT00446706

Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)

Status
Completed
Phase
Study type
Observational
Enrollment
6 (actual)
Sponsor
Texas Tech University Health Sciences Center, El Paso · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

ARDS (Acute Respiratory Distress Syndrome) is a condition of severe inflammation and excess fluids in the lungs that impairs their function of oxygen uptake to the point of needing a ventilator (breathing machine) to help them obtain enough oxygen into the body. Because of the high amounts of gas that the ventilator has to give to these patients, high pressures may develop deep into the lungs and produce complications for the patient. However, physicians sometimes cannot recognize it because it requires special equipment to measure pressure deep in the lungs. The goal of this study is to determine if the amount of this pressure can be calculated using mathematical formulas and the routine numbers provided by ventilators. The study consists on making the conventional measurement of this deep pressure and at the same time calculate this same pressure from other measurements that the ventilator routinely provides, to see if the calculated value can replace the more complicated conventional measurement. The measurements will be done by: 1. placing a small device along the tubing connecting the patient to the ventilator; 2. giving medicines to relax the muscles (if the patient is not already receiving them); and 3. making the ventilator hold the patient's breath for a few seconds to take measurements. This is repeated after the breathing rate of the ventilator is increased or decreased mildly. Risks related to the medicine to be used and the measuring maneuvers are rare but include transient narrowing of windpipes, transiently low heart rate, blood pressure or blood oxygen, and allergic reactions. This is not a treatment. The information obtained during the study will be shared with the treating doctors who may find it useful to make adjustments to the ventilator. The patient may receive no direct benefit from being in this study; however, the findings may contribute to better care for this kind of patients in the future.

Detailed description

Intrinsic PEEP (Positive-End Expiratory Pressure) was measured by end-expiratory occlusion method and estimated using formulas derived from measured expiratory flows and a postulated linear pressure-flow relationship during expiration in passive ARDS patients. Agreement between measured and estimated intrinsic PEEP was analyzed by Bland and Altman's method.

Conditions

Timeline

Start date
2004-01-01
Primary completion
2007-04-01
Completion
2007-04-01
First posted
2007-03-13
Last updated
2017-05-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00446706. Inclusion in this directory is not an endorsement.