Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446706
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2007-03-12
Brief Title:
Estimation of Intrinsic Positive End-Expiratory Pressure PEEP in Acute Respiratory Distress Syndrome ARDS
Sponsor:
Texas Tech University Health Sciences Center El Paso
Organization:
Texas Tech University Health Sciences Center El Paso
Study Overview
Official Title:
Estimation of Intrinsic Positive End-Expiratory Pressure PEEP in Acute Respiratory Distress Syndrome ARDS
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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 Altmans method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None