Acute Respiratory Distress SyndromeNCT03076450
Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
A study testing Lung Ultrasound and Maximum Oxygenation in people with Acute Respiratory Distress Syndrome, run by Shanghai Pudong New Area Gongli Hospital at 1 site in China.
Trial summary
Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Lung Ultrasound and Maximum Oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Sep 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged 18 years and older
- ARDS patients with invasive mechanical ventilation
Who cannot join
- Intracranial hypertension
- Pneumothorax and mediastinal emphysema
- Severe hypoxemia (oxygenation index <100)
- Hemodynamic instability
- Chest deformity or surgical history
- Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gongli Hospital
Pudong, Shanghai Municipality, 200135
Qiancheng Luo, MM, 008613564781737, luoqiancheng19@163.com
About this study
Official title: Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.
Read the detailed description
The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Lung Ultrasound, Maximum Oxygenation
- Keywords
- Acute respiratory distress syndrome, ARDS, Point-of-care lung ultrasound,POC-LUS, Pressure-volume curve, PVC, Positive end-expiratory pressure, PEEP, Ultrasound re-aeration score, US-RAS
- Medical subject headings
- Respiratory Distress Syndrome, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDevice
Adjust PEEP real-time in term of LUS-RAS chang.
Maximum OxygenationDiagnostic test
Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.
| Study group | Role | What they receive |
|---|---|---|
| Maximum Oxygenation | Active comparator | Using PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP. Receives: Diagnostic Test: Maximum Oxygenation |
| Lung Ultrasound Re-aeration Score | Experimental | Combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Receives: Device: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Ultrasound re-aeration score, LUS-RAS
The score is composed of 12 different regions of chest wall checked by POC-LUS.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Sep 2018 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong New Area Gongli Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning
- Responsible party
- Principal investigator, Qiancheng Luo, Shanghai Pudong New Area Gongli Hospital
- Investigators
- Qiancheng Luo, MM, Principal investigator, Shanghai Pudong New Area Gongli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076450
- Sponsor's protocol ID
- 201640405
- Status last verified
- Apr 2017
- First submitted
- 7 Mar 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
- ClinicalTrials.gov ID
- NCT03076450
- Acronym / sponsor ID
- 201640405
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, ARDS, Point-of-care lung ultrasound,POC-LUS, Pressure-volume curve, PVC, Positive end-expiratory pressure, PEEP, Ultrasound re-aeration score, US-RAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Pudong New Area Gongli HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 10 Mar 2017 (actual)
- 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.
Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.
Detailed description
The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximum Oxygenation | Active comparator | Diagnostic Test: Maximum OxygenationUsing PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP. |
| Lung Ultrasound Re-aeration Score | Experimental | Device: Lung UltrasoundCombine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient aged 18 years and older
- ARDS patients with invasive mechanical ventilation
Key exclusion criteria (6 listed)
- Intracranial hypertension
- Pneumothorax and mediastinal emphysema
- Severe hypoxemia (oxygenation index <100)
- Hemodynamic instability
- Chest deformity or surgical history
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 |
|---|---|---|
| Lung UltrasoundAdjust PEEP real-time in term of LUS-RAS chang. | Device | Lung Ultrasound Re-aeration Score |
| Maximum OxygenationAdjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not. | Diagnostic test | Maximum Oxygenation |
Primary outcome
Lung Ultrasound re-aeration score, LUS-RAS
Time frame: 48 hours
The score is composed of 12 different regions of chest wall checked by POC-LUS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: Yes
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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.
Qiancheng Luo, MM principal investigator
Shanghai Pudong New Area Gongli 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 Lung Ultrasound and Maximum Oxygenation in people with Acute Respiratory Distress Syndrome, run by Shanghai Pudong New Area Gongli 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 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: status not confirmed, as of the sponsor's last update on 2 May 2017. 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 Qiancheng Luo, MM (008613564781737, luoqiancheng19@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Ultrasound re-aeration score, LUS-RAS (time frame: 48 hours). 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 2 May 2017.