Short Term Outcomes of Children With Acute Respiratory Distress Syndrome

NCT ID: NCT00142376

Last Updated: 2005-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Rapidly progressive respiratory failure,
* Severe hypoxemia (PaO2/FiO2 \< 200),
* Evidence of bilateral pulmonary infiltrate on chest radiography
* 0-18 years of age

Exclusion Criteria

* Heart failure
* Cardiac shunt present
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nationwide Children's Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Onsy Ayad, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbus Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 7509706 (View on PubMed)

Davis 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.

Reference Type BACKGROUND
PMID: 8320623 (View on PubMed)

Timmons 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.

Reference Type BACKGROUND
PMID: 7656635 (View on PubMed)

Katz R. Adult respiratory distress syndrome in children. Clin Chest Med. 1987 Dec;8(4):635-9.

Reference Type BACKGROUND
PMID: 3322648 (View on PubMed)

Timmons 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.

Reference Type BACKGROUND
PMID: 1960603 (View on PubMed)

Milberg 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.

Reference Type BACKGROUND
PMID: 7815658 (View on PubMed)

Acute 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.

Reference Type BACKGROUND
PMID: 10793162 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0409HSE222

Identifier Type: -

Identifier Source: org_study_id