Acute Respiratory Distress SyndromeNCT00142376
Short Term Outcomes of Children With Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The study is a chart review of all children admitted over a two year period with the diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality, length of ventilation and length of stay, will be reviewed. Factors that impact these outcomes will also be reviewed. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2005
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Rapidly progressive respiratory failure,
- Severe hypoxemia (PaO2/FiO2 < 200),
- Evidence of bilateral pulmonary infiltrate on chest radiography
- 0-18 years of age
Who cannot join
- Heart failure
- Cardiac shunt present
Trial locations and contacts
1 site in 1 country.
About this study
The study is a chart review of all children admitted over a two year period with the diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality, length of ventilation and length of stay, will be reviewed. Factors that impact these outcomes will also be reviewed.
Read the detailed description
We would like to conduct a chart review of all patients with pediatric ARDS hospitalized in the PICU at Columbus Children's Hospital in the last two years. Patients would be included for review if they met the clinical criteria for ARDS. These criteria are: rapidly progressive respiratory failure, severe hypoxemia (PaO2/FiO2 < 200), and evidence of bilateral pulmonary infiltrate on chest radiography. We estimate 40-50 patients will meet criteria.
Once criteria are met, patient charts will be pulled or reviewed electronically. We will then compose a database that includes no patient identifiers but contains information regarding the cause, length, and outcome of the ARDS admission and PICU stay. Factors such as nutritional status, antibiotic and muscle relaxant use, and type of ventilation used will be examined. Other care-related variables will be included if they are felt to impact outcome during the review process. The database will then be analyzed and information regarding pediatric ARDS outcomes in our institution will be published.
We anticipate that examining the factors that impact short term outcomes in pediatric ARDS will lead to research possibilities regarding ways to improve both short and long term outcomes in children with this illness. We propose that reviewing the disease entity as a whole will lead to improvements in caring for children with the disease, and eventually bring about a decline in mortality rates.
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Onsy Ayad, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142376
- Sponsor's protocol ID
- 0409HSE222
- Status last verified
- Sep 2004
- First submitted
- 1 Sep 2005
- Last updated
- 2 Sep 2005
- Results posted
- No
Publications
Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. doi: 10.1164/ajrccm.149.3.7509706.
PubMed 7509706Davis SL, Furman DP, Costarino AT Jr. Adult respiratory distress syndrome in children: associated disease, clinical course, and predictors of death. J Pediatr. 1993 Jul;123(1):35-45. doi: 10.1016/s0022-3476(05)81534-3.
PubMed 8320623Timmons OD, Havens PL, Fackler JC. Predicting death in pediatric patients with acute respiratory failure. Pediatric Critical Care Study Group. Extracorporeal Life Support Organization. Chest. 1995 Sep;108(3):789-97. doi: 10.1378/chest.108.3.789.
PubMed 7656635Katz R. Adult respiratory distress syndrome in children. Clin Chest Med. 1987 Dec;8(4):635-9.
PubMed 3322648Timmons OD, Dean JM, Vernon DD. Mortality rates and prognostic variables in children with adult respiratory distress syndrome. J Pediatr. 1991 Dec;119(6):896-9. doi: 10.1016/s0022-3476(05)83039-2.
PubMed 1960603Milberg JA, Davis DR, Steinberg KP, Hudson LD. Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983-1993. JAMA. 1995 Jan 25;273(4):306-9.
PubMed 7815658Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes of Children With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00142376
- Acronym / sponsor ID
- 0409HSE222
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Aug 2005
- First posted
- 2 Sep 2005 (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.
The study is a chart review of all children admitted over a two year period with the diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality, length of ventilation and length of stay, will be reviewed. Factors that impact these outcomes will also be reviewed.
Detailed description
We would like to conduct a chart review of all patients with pediatric ARDS hospitalized in the PICU at Columbus Children's Hospital in the last two years. Patients would be included for review if they met the clinical criteria for ARDS. These criteria are: rapidly progressive respiratory failure, severe hypoxemia (PaO2/FiO2 < 200), and evidence of bilateral pulmonary infiltrate on chest radiography. We estimate 40-50 patients will meet criteria.
Once criteria are met, patient charts will be pulled or reviewed electronically. We will then compose a database that includes no patient identifiers but contains information regarding the cause, length, and outcome of the ARDS admission and PICU stay. Factors such as nutritional status, antibiotic and muscle relaxant use, and type of ventilation used will be examined. Other care-related variables will be included if they are felt to impact outcome during the review process. The database will then be analyzed and information regarding pediatric ARDS outcomes in our institution will be published.
We anticipate that examining the factors that impact short term outcomes in pediatric ARDS will lead to research possibilities regarding ways to improve both short and long term outcomes in children with this illness. We propose that reviewing the disease entity as a whole will lead to improvements in caring for children with the disease, and eventually bring about a decline in mortality rates.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Rapidly progressive respiratory failure,
- Severe hypoxemia (PaO2/FiO2 < 200),
- Evidence of bilateral pulmonary infiltrate on chest radiography
- 0-18 years of age
Key exclusion criteria (2 listed)
- Heart failure
- Cardiac shunt present
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
Not reported in the source record.
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 2 Sep 2005.
- Background: PubMed 7509706Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. doi: 10.1164/ajrccm.149.3.7509706.
- Background: PubMed 8320623Davis SL, Furman DP, Costarino AT Jr. Adult respiratory distress syndrome in children: associated disease, clinical course, and predictors of death. J Pediatr. 1993 Jul;123(1):35-45. doi: 10.1016/s0022-3476(05)81534-3.
- Background: PubMed 7656635Timmons OD, Havens PL, Fackler JC. Predicting death in pediatric patients with acute respiratory failure. Pediatric Critical Care Study Group. Extracorporeal Life Support Organization. Chest. 1995 Sep;108(3):789-97. doi: 10.1378/chest.108.3.789.
- Background: PubMed 3322648Katz R. Adult respiratory distress syndrome in children. Clin Chest Med. 1987 Dec;8(4):635-9.
- Background: PubMed 1960603Timmons OD, Dean JM, Vernon DD. Mortality rates and prognostic variables in children with adult respiratory distress syndrome. J Pediatr. 1991 Dec;119(6):896-9. doi: 10.1016/s0022-3476(05)83039-2.
- Background: PubMed 7815658Milberg JA, Davis DR, Steinberg KP, Hudson LD. Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983-1993. JAMA. 1995 Jan 25;273(4):306-9.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
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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.
Onsy Ayad, MD principal investigator
Nationwide Children's Hospital
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 Nationwide Children's Hospital 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 4 inclusion and 2 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 2 Sep 2005. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142376, which also lists 7 linked publications.
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 2 Sep 2005.