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Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Southeast University, China.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01677130
First received: August 29, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients of ARDS age> 18 years

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ling Liu, Physician Zhongda Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT01677130     History of Changes
Other Study ID Numbers: FOV application
Study First Received: August 29, 2012
Last Updated: August 30, 2012
Health Authority: Food and Drug Administration:China

Keywords provided by Southeast University, China:
Clinical efficacy
safety
of HFOV treatment
of patients

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014