Acute Respiratory Distress SyndromeNCT01677130
Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by Ling Liu.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of ARDS age> 18 years
Who may be able to join
- 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.
Who cannot join
- severe pulmonary hemorrhage;
- severe intracranial high pressure;
- large airway stenosis and airway obstruction.
About this study
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Clinical efficacy, safety, of HFOV treatment, of patients
- 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 posted31 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ling Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677130
- Sponsor's protocol ID
- FOV application
- Status last verified
- Dec 2016
- First submitted
- 29 Aug 2012
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT01677130
- Acronym / sponsor ID
- FOV application
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Clinical efficacy, safety, of HFOV treatment, of patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ling LiuUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Aug 2012 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of ARDS age> 18 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- severe pulmonary hemorrhage;
- severe intracranial high pressure;
- large airway stenosis and airway obstruction.
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 6 Dec 2016.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Ling Liu.
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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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 6 Dec 2016.