ArdsNCT03763890
Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients
An observational study of Ards, run by Southeast University, China at 1 site in China.
Trial summary
This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ards
- What is being tested?
- Post-end-Expiratory pressure
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Moderate or sever ARDS in 2012 <Berlin definition>;
Who may be able to join
- Age≥18 or<80；
- Moderate or sever ARDS in 2012 <Berlin definition>;
- Applied mechanical ventilation;
- Consent signed.
Who cannot join
- Asthma or COPD；
- Cardiogenic edema；
- Sever neutropenia(<500/mm3)；
- Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min；
- GCS coma score ≤12；
- Thoracic injury or surgery patients contradict EIT ；
- Refuse to join in trail；
- Included in other clinical trail。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, 210009
Ling Liu, MD., 86-25-83272201, liulingdoctor@126.com
Haibo Qiu, PhD.,MD., 86-25-83272200, haiboq2000@yahoo.com.cn
About this study
This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
Read the detailed description
ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
- Conditions
- Ards
- Being tested
- Post-end-Expiratory pressure
- Keywords
- ARDS（Acute respiratory syndrome）;, stress;, strain;, Trans-pulmonary pressure;, FRC(functional residual capacity ), PEEP（post end-expiratory pressure）;, EIT（Electronic impedance tomography）;, RVD(region ventilation delay)
- Medical subject headings
- Acute Lung Injury, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-end-Expiratory pressureDevice
Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar hyper-distention; alveolar collapse；alveolar opening and closing；
The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).
Measured: September,1,2018-December 30, 2020
Trans-pulmonary pressure
The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress
Measured: September,1,2018-December 30, 2020
EELV
The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain
Measured: September,1,2018-December 30, 2020
peak pressure
The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..
Measured: September,1,2018-December 30, 2020
plateau pressure
The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.
Measured: September,1,2018-December 30, 2020
tidal volume
The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..
Measured: September,1,2018-December 30, 2020
respiratory rate
The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.
Measured: September,1,2018-December 30, 2020
flow
The researchers record the set Flow (L/min) in patients with mechanical ventilation.
Measured: September,1,2018-December 30, 2020
FiO2
The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.
Measured: September,1,2018-December 30, 2020
PaO2
The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)
Measured: September,1,2018-December 30, 2020
PaCO2
The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .
Measured: September,1,2018-December 30, 2020
Secondary outcomes (4)
SBP
Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
Measured: September,1,2018-December 30, 2020
DBP
Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
Measured: September,1,2018-December 30, 2020
CVP
Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).
Measured: September,1,2018-December 30, 2020
vasopressor
Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)
Measured: September,1,2018-December 30, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArdsStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- haibo qiu, PhD, Study director, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763890
- Sponsor's protocol ID
- 20181129PEEP
- Status last verified
- Jul 2022
- First submitted
- 29 Nov 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients
- ClinicalTrials.gov ID
- NCT03763890
- Acronym / sponsor ID
- 20181129PEEP
- Conditions
- Ards
- Keywords
- ARDS（Acute respiratory syndrome）;, stress;, strain;, Trans-pulmonary pressure;, FRC(functional residual capacity ), PEEP（post end-expiratory pressure）;, EIT（Electronic impedance tomography）;, RVD(region ventilation delay)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Dec 2018 (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.
This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
Detailed description
ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate or sever ARDS in 2012 <Berlin definition>;
Key inclusion criteria (4 listed)
- Age≥18 or<80；
- Moderate or sever ARDS in 2012 <Berlin definition>;
- Applied mechanical ventilation;
- Consent signed.
Key exclusion criteria (8 listed)
- Asthma or COPD；
- Cardiogenic edema；
- Sever neutropenia(<500/mm3)；
- Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min；
- GCS coma score ≤12；
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 |
|---|---|---|
| Post-end-Expiratory pressureTitrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis. | Device | – |
Primary outcome
alveolar hyper-distention; alveolar collapse；alveolar opening and closing；
Time frame: September,1,2018-December 30, 2020
The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).
Trans-pulmonary pressure
Time frame: September,1,2018-December 30, 2020
The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress
EELV
Time frame: September,1,2018-December 30, 2020
The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain
peak pressure
Time frame: September,1,2018-December 30, 2020
The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..
plateau pressure
Time frame: September,1,2018-December 30, 2020
The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.
tidal volume
Time frame: September,1,2018-December 30, 2020
The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..
respiratory rate
Time frame: September,1,2018-December 30, 2020
The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.
flow
Time frame: September,1,2018-December 30, 2020
The researchers record the set Flow (L/min) in patients with mechanical ventilation.
FiO2
Time frame: September,1,2018-December 30, 2020
The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.
PaO2
Time frame: September,1,2018-December 30, 2020
The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)
PaCO2
Time frame: September,1,2018-December 30, 2020
The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .
4 secondary outcomes
SBP
Time frame: September,1,2018-December 30, 2020
DBP
Time frame: September,1,2018-December 30, 2020
CVP
Time frame: September,1,2018-December 30, 2020
vasopressor
Time frame: September,1,2018-December 30, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- 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.
haibo qiu, PhD study director
Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ards, 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 4 inclusion and 8 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 19 Jul 2022. 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 ling Liu, Phd (13851435472, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alveolar hyper-distention; alveolar collapse；alveolar opening and closing； (time frame: September,1,2018-December 30, 2020). The study lists 11 primary outcomes in all. 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 19 Jul 2022.