Acute Respiratory Distress SyndromeNCT02639364
Airway Pressure Release Ventilation (APRV) Protocol Early Used in Acute Respiratory Distress Syndrome
A study testing Nellcor Puritan Bennett 840 ventilator system in people with Acute Respiratory Distress Syndrome, run by West China Hospital at 1 site in China.
Trial summary
The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Nellcor Puritan Bennett 840 ventilator system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
- A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.
Who cannot join
- Pregnancy
- The expected duration of mechanical ventilation was less than 48 hours
- Intracranial hypertension (suspected or confirmed)
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- Known or suspected chronic obstructive pulmonary disease(COPD)
- Preexisting conditions with an expected 6-month mortality exceeding 50%
Show all 9Show fewer
- Pneumothorax (drained or not)at enrollment
- Treatment with extracorporeal support (ECMO) at enrollment
- There was a lack of commitment to life support.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, 610041
Y F zhou, MM, 8613880012276
Y F Zhou, MM
About this study
Official title: the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients
The aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
Read the detailed description
Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.
The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Nellcor Puritan Bennett 840 ventilator system
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellcor Puritan Bennett 840 ventilator systemDevice
Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.
| Study group | Role | What they receive |
|---|---|---|
| conventional ventilation strategy | Active comparator | The conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level. Receives: Device: Nellcor Puritan Bennett 840 ventilator system |
| BILEVEL-APRV protocol | Experimental | According to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing. Receives: Device: Nellcor Puritan Bennett 840 ventilator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation free days
Measured: day 28
Secondary outcomes (19)
all causes mortality
Participants will be followed for the duration of ICU stay
Measured: day 60
all cause hospital mortality
Participants will be followed for the duration of hospital stay, until day 60 maximum.
Measured: day 60
Duration of stay in ICU
Measured: day 60
Duration of hospital stay
Measured: day 60
peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
Measured: day 7
Average dosage of sedative infusion
Measured: day 7
Richmond Sedation-Agitation Scale
Measured: day 7
Average dosage of vasoactive drugs each day in use
Measured: day 7
number of patients requiring cointerventions and Adjunctive Therapies
Measured: Day 28
number of patients requiring the use of noninvasive ventilation
Measured: Day 28
the tracheotomy rate
Measured: Day 28
Number of patients with a pneumothorax
Measured: Day 28
the number of days free from organ dysfunction
Measured: Day 28
tidal volume(ml)
Measured: Day 7
static lung compliance（ml/cmH2O）
Measured: Day 7
PaO2,PaCO2(mmHg)
Measured: Day 7
Blood pressure(mmHg)
Measured: Day 7
blood lactic acid（mmol/l）
Measured: Day 7
minute ventilation (L)
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yongfang, West China Hospital
- Investigators
- Yan Kang, doctor, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639364
- Sponsor's protocol ID
- 2015 approval (156)
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects and Safety of the Early Application of Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVEL-APRV) Protocol and Conventional Ventilation Strategy Were Compared in ARDS Patients
- ClinicalTrials.gov ID
- NCT02639364
- Acronym / sponsor ID
- 2015 approval (156)
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Dec 2015 (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 aim of this study is to assess the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
Detailed description
Although mechanical ventilation is life-sustaining for patients with ARDS, it can perpetuate lung injury. A number of recent advances have greatly improved in the mechanical ventilation strategies and treatment for acute respiratory distress syndrome (ARDS), however, Mortality remains high, even with the use of low tidal volume and adequate positive end expiratory pressure(PEEP). Numerous experimental showed that the BILEVEL-APRV mode used in animal ARDS model can improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the dosage for sedative drugs.
The aim of this single-center, prospective, randomized, controlled, open study is to compare the effects and safety of the early application of BILEVEL-APRV protocol and conventional ventilation strategy that used low tidal volume and adequate PEEP level in ARDS patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ventilation strategy | Active comparator | Device: Nellcor Puritan Bennett 840 ventilator systemThe conventional ventilation strategy use volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) mode, combination with low tidal volume and adequate PEEP level. |
| BILEVEL-APRV protocol | Experimental | Device: Nellcor Puritan Bennett 840 ventilator systemAccording to our BILEVEL-APRV protocol, BILEVEL-APRV APRV mode with specific settings,combination with spontaneous breathing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute respiratory distress syndrome,according to the Berlin definition of ARDS, - The receipt of endotracheal mechanical ventilation for a period was no longer than 48 hours
- A ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen(FiO2) was less than 250.
Key exclusion criteria (9 listed)
- Pregnancy
- The expected duration of mechanical ventilation was less than 48 hours
- Intracranial hypertension (suspected or confirmed)
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- Known or suspected chronic obstructive pulmonary disease(COPD)
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 |
|---|---|---|
| Nellcor Puritan Bennett 840 ventilator systemPuritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode. | Device | BILEVEL-APRV protocol, conventional ventilation strategy |
Primary outcome
Mechanical ventilation free days
Time frame: day 28
19 secondary outcomes
all causes mortality
Time frame: day 60
all cause hospital mortality
Time frame: day 60
Duration of stay in ICU
Time frame: day 60
Duration of hospital stay
Time frame: day 60
peak airway pressure,mean airway pressure,positive end expiratory pressure(cmH2O)
Time frame: day 7
Average dosage of sedative infusion
Time frame: day 7
Richmond Sedation-Agitation Scale
Time frame: day 7
Average dosage of vasoactive drugs each day in use
Time frame: day 7
number of patients requiring cointerventions and Adjunctive Therapies
Time frame: Day 28
number of patients requiring the use of noninvasive ventilation
Time frame: Day 28
the tracheotomy rate
Time frame: Day 28
Number of patients with a pneumothorax
Time frame: Day 28
the number of days free from organ dysfunction
Time frame: Day 28
tidal volume(ml)
Time frame: Day 7
static lung compliance（ml/cmH2O）
Time frame: Day 7
PaO2,PaCO2(mmHg)
Time frame: Day 7
Blood pressure(mmHg)
Time frame: Day 7
blood lactic acid（mmol/l）
Time frame: Day 7
minute ventilation (L)
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Yan Kang, doctor study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nellcor Puritan Bennett 840 ventilator system in people with Acute Respiratory Distress Syndrome, run by West China Hospital 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongfang Zhou, master (8618140212276, zyfmg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation free days (time frame: day 28). 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 Dec 2015.