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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00446706
First received: March 12, 2007
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Agreement between Measured and Estimated Intrinsic PEEP [ Time Frame: The day and time of measurement ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: January 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with Acute Respiratory Distress Syndrome

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446706

Locations
United States, Texas
Thomason Hospital (Now University Medical Center)
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Juan Figueroa-Casas, MD Texas Tech University
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00446706     History of Changes
Other Study ID Numbers: Estimation PEEPi
Study First Received: March 12, 2007
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Intrinsic PEEP

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 28, 2014