Respiratory FailureNCT02814994
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
A study testing tidal volume guided by respiratory system compliance and low tidal volume in people with Respiratory Failure and Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
Trial summary
The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Acute Respiratory Distress Syndrome
- What is being tested?
- tidal volume guided by respiratory system compliance and low tidal volume
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Jun 2014
- Phase
- Interventional
- 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
Who may be able to join
- aged ≥ 18 years
- admitted to the ICU
- according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS
Who cannot join
- age <18 years old
- be expected to die within 24 hours
- end-stage malignancies
- be participating in other studies, which may affect the results of this study
- DNI (do not intubation) and DNR (do not recovery) patients
- family members do not agree to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory System Compliance Guided Tidal Volume in Moderate to Severe ARDS Patients: A Multicenter Randomized Controlled Study
The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.
Read the detailed description
From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.
- Being tested
- tidal volume guided by respiratory system compliance, low tidal volume
- Keywords
- Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tidal volume guided by respiratory system complianceBehavioural
ventilated with tidal volume guided by respiratory system compliance
low tidal volumeBehavioural
ventilation ventilated with low tidal volume
| Study group | Role | What they receive |
|---|---|---|
| tidal volume guided by respiratory system compliance | Experimental | effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS Receives: Behavioral: tidal volume guided by respiratory system compliance |
| low tidal volume | Experimental | Ventilated patients with low tidal volume Receives: Behavioral: low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Haibo Qiu, Prof., Study director, southeast university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814994
- Sponsor's protocol ID
- ARDS protocol treatment
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory System Compliance Guided Tidal Volume in Moderate to Severe ARDS Patients: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02814994
- Acronym / sponsor ID
- ARDS protocol treatment
- Keywords
- Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Jun 2016 (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 one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.
Detailed description
From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tidal volume guided by respiratory system compliance | Experimental | Behavioral: tidal volume guided by respiratory system complianceeffects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS |
| low tidal volume | Experimental | Behavioral: low tidal volumeVentilated patients with low tidal volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 18 years
- admitted to the ICU
- according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS
Key exclusion criteria (6 listed)
- age <18 years old
- be expected to die within 24 hours
- end-stage malignancies
- be participating in other studies, which may affect the results of this study
- DNI (do not intubation) and DNR (do not recovery) patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tidal volume guided by respiratory system complianceventilated with tidal volume guided by respiratory system compliance | Behavioural | tidal volume guided by respiratory system compliance |
| low tidal volumeventilation ventilated with low tidal volume | Behavioural | low tidal volume |
Primary outcome
the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS
Time frame: 28-days
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 28 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Haibo Qiu, Prof. study director
southeast university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tidal volume guided by respiratory system compliance and low tidal volume in people with Respiratory Failure and Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
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 6 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 28 Jun 2016. 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 China. 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.
What does the primary outcome measure?
the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS (time frame: 28-days). It is what the study was designed to measure, not a finding.
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 28 Jun 2016.