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

Completed

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT00446706

Run by

Texas Tech University Health Sciences Center, El Paso

People needed

6

Starts

2004-01-01

Expected to finish

2007-04-01

Last updated by the study team

2017-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older with diagnosis of ARDS, as defined by the American- European Consensus Conference 4
• Receiving mechanical ventilation.
• Presence of autoPEEP by inspection of flow-time waveforms displayed by the mechanical ventilator.

You may not qualify if…

• Known or suspected diagnosis of COPD or airflow limitation.
• Next of kin not available to consent.
• Contraindication to receive a muscle relaxant when measurements may be inaccurate without its administration.
• Pregnancy

Where it is running

• Thomason Hospital (Now University Medical Center) — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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