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

NCT00446706 | Completed

• 1 other identifier: Estimation PEEPi
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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. 1.placing a small device along the tubing connecting the patient to the ventilator;
2. 2.giving medicines to relax the muscles (if the patient is not already receiving them); and
3. 3.making the ventilator hold the patient's breath for a few seconds to take measurements.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Intrinsic PEEP

Outcome Measures

Primary Outcomes (1)

• Agreement between Measured and Estimated Intrinsic PEEP

  Bias and its standard deviation

  The day and time of measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Acute Respiratory Distress Syndrome

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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Thomason Hospital (Now University Medical Center)

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency

Study Officials

• Juan Figueroa-Casas, MD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: January 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)