- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677130
Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)
December 5, 2016 updated by: Ling Liu
The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea and refractory hypoxemia caused by various reasons.
Although in recent years a variety of supportive care measures have significant progress, but the mortality rate of patients with ARDS is still as high as 35-40%.
Mechanical ventilation is one of the main treatments with ARDS, which is widely used in clinical.
The rational mechanical ventilation strategy can improve the oxygenation of patients with ARDS and reduce lung injury.
Patients with ARDS usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion has heterogeneity.
The protective mechanical ventilation strategies chosen by patients with ARDS in clinical practice are gradually being accepted and applied.
The High-frequency oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal volume.
Compared with conventional mechanical ventilation, HFOV may be able to more effectively improve oxygenation and reduce ventilator-associated lung injury.
HFOV and protective ventilation strategy in ARDS is consistent with an important position in the treatment of ARDS, but not been widely adopted in clinical practice and is still only as a salvage treatment.
Therefore, this study intends to use HFOV treatment with conventional mechanical ventilation by matching the cases in patients with ARDS.
By comparing the influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety, and health economics effectiveness of HFOV are further investigated and adaption time and parameter settings of HFOV are explored, which provide better treatment options for patients with ARDS and improve their prognosis.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
24
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients of ARDS age> 18 years
Description
Inclusion Criteria:
- age> 18 years;
- lung protective ventilation (tidal volume 4-6ml/kg), airway plateau pressure is still higher than 30cmH2O, or the failure of conventional mechanical ventilation pneumothorax, bronchopleural fistula in patients with ARDS; of ARDS diagnosis in line with the 2012 Berlin ARDS diagnostic criteria.
- be able to sign informed consent.
Exclusion Criteria:
- severe pulmonary hemorrhage;
- severe intracranial high pressure;
- large airway stenosis and airway obstruction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
August 29, 2012
First Submitted That Met QC Criteria
August 30, 2012
First Posted (ESTIMATE)
August 31, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 6, 2016
Last Update Submitted That Met QC Criteria
December 5, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOV application
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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