Acute Respiratory Distress SyndromeNCT00446706
Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Acute Respiratory Distress Syndrome
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomason Hospital (Now University Medical Center)
El Paso, Texas, 79905
About this study
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:
- placing a small device along the tubing connecting the patient to the ventilator;
- giving medicines to relax the muscles (if the patient is not already receiving them); and
- 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.
Read the 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
- Acute Respiratory Distress Syndrome
- Keywords
- Intrinsic PEEP
- Medical subject headings
- Respiratory Distress Syndrome, Positive-Pressure Respiration, Intrinsic
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Measured and Estimated Intrinsic PEEP
Bias and its standard deviation
Measured: The day and time of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJan 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan B. Figueroa-Casas, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Juan Figueroa-Casas, MD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446706
- Sponsor's protocol ID
- Estimation PEEPi
- Status last verified
- May 2017
- First submitted
- 12 Mar 2007
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Intrinsic Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT00446706
- Acronym / sponsor ID
- Estimation PEEPi
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Intrinsic PEEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- placing a small device along the tubing connecting the patient to the ventilator;
- giving medicines to relax the muscles (if the patient is not already receiving them); and
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Acute Respiratory Distress Syndrome
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between Measured and Estimated Intrinsic PEEP
Time frame: The day and time of measurement
Bias and its standard deviation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Figueroa-Casas, MD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between Measured and Estimated Intrinsic PEEP (time frame: The day and time of measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.