ARDSNCT00656071
Retrospective Postoperative ARDS Study at Vanderbilt University
An observational study of ARDS, run by Vanderbilt University at 1 site in United States.
Trial summary
By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- ARDS
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2008
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The surgical and post-op patients at VUMC. The collection dates will be from October 1, 2001 until August 31, 2007.
Who may be able to join
- ARDS
- post-surgical
- ventilator
Who cannot join
- rib fracture
- pneumonia
- sepsis
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Intraoperative Anesthetic Characteristics and the Development of ARDS
By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.
- Conditions
- ARDS
- Keywords
- ARDS, Acute respiratory distress syndrome, Adult respiratory distress syndrome, respiratory distress
- Medical subject headings
- Respiratory Distress Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Control -- postoperative mechanical ventilation patients without ARDS | |
| 2 | Cases -- postoperative mechanical ventilation patients with ARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARDS
Measured: data pulled from 10/2000 - 08/2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hughes, Vanderbilt University
- Investigators
- Christopher G Hughes, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656071
- Sponsor's protocol ID
- CHughes-PGY2
- Status last verified
- Sep 2012
- First submitted
- 4 Apr 2008
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Anesthetic Characteristics and the Development of ARDS
- ClinicalTrials.gov ID
- NCT00656071
- Acronym / sponsor ID
- CHughes-PGY2
- Conditions
- ARDS
- Keywords
- ARDS, Acute respiratory distress syndrome, Adult respiratory distress syndrome, respiratory distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Apr 2008 (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.
By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.
Detailed description
Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Control -- postoperative mechanical ventilation patients without ARDS |
| 2 | – | –Cases -- postoperative mechanical ventilation patients with ARDS |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The surgical and post-op patients at VUMC. The collection dates will be from October 1, 2001 until August 31, 2007.
Key inclusion criteria (3 listed)
- ARDS
- post-surgical
- ventilator
Key exclusion criteria (3 listed)
- rib fracture
- pneumonia
- sepsis
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
ARDS
Time frame: data pulled from 10/2000 - 08/2007
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 7 Sep 2012.
- Vanderbilt Department of AnesthesiologyLink provided by the sponsor.
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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.
Christopher G Hughes, M.D. principal investigator
Vanderbilt University Medical Center
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 ARDS, run by Vanderbilt University 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 3 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 7 Sep 2012. 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?
ARDS (time frame: data pulled from 10/2000 - 08/2007). 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 7 Sep 2012.