ARDSNCT05207267
Driving Pressure Guided VT in ARDS Patients
A study testing driving pressure guided tidal volume in people with ARDS, run by Southeast University, China at 1 site in China.
Trial summary
A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- driving pressure guided tidal volume
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years old
- admitted to intensive care unit with a moderate to severe ARDS
- invasive mechanical ventilation
Who cannot join
- contraindications for prone position ventilation
- Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
- New York Heart Association class above II
- gave written or witnessed verbal informed consent.
- Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
- Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT
A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.
Read the detailed description
Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).
Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2).
Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase，the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected.
- Conditions
- ARDS
- Being tested
- driving pressure guided tidal volume
- Keywords
- ARDS, ventilation and perfusion matching, ventilation inhomogeneity
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
driving pressure guided tidal volumeDevice
Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position.
| Study group | Role | What they receive |
|---|---|---|
| testing arm | Experimental | ventilated with different VT using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) Receives: Device: driving pressure guided tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional compliance using EIT
regional compliance using EIT
Measured: Day 1
regional ventilation
regional ventilation using EIT
Measured: Day 1
regional perfusion
regional perfusion using EIT
Measured: Day 1
Region-ventilation-delay
Region-ventilation-delay using EIT
Measured: Day 1
driving pressure
measurement as one index of respiratory compliance
Measured: Day 3
the number of regional lung ventilation
regional ventilation measuring by EIT
Measured: Day 3
the number of regional lung perfusion
regional perfusion measuring by EIT
Measured: Day 3
the number of region-ventilation-delay (RVD)
the RVD measuring by EIT
Measured: Day 3
Secondary outcomes (9)
Value of ventilation-perfusion (V/Q) mismatch
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
Measured: Day 1
Value of ventilation-perfusion (V/Q) mismatch
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated
Measured: Day 3
Value of ventilation-perfusion (V/Q) mismatch
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated
Measured: Day 7
The Global Inhomogeneity (GI) index
higher values indicating less homogenous ventilation
Measured: Day 1
The Global Inhomogeneity (GI) index
higher values indicating less homogenous ventilation
Measured: Day 3
The Global Inhomogeneity (GI) index
higher values indicating less homogenous ventilation
Measured: Day 7
Blood gas
PaO2
Measured: Day 1
Ventilation free day
ventilation free day in day 28
Measured: Day 28
28 day mortality
death in day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start30 Jun 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, Study director, Zhongda Hospital, School of Medicine, Southeast Univerty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207267
- Sponsor's protocol ID
- Ling-driving pressure
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by email
Publications
Yuan X, Zhao Z, Chao Y, Chen D, Chen H, Zhang R, Liu S, Xie J, Yang Y, Qiu H, Heunks L, Liu L. Effects of early versus delayed application of prone position on ventilation-perfusion mismatch in patients with acute respiratory distress syndrome: a prospective observational study. Crit Care. 2023 Nov 27;27(1):462. doi: 10.1186/s13054-023-04749-3.
PubMed 38012731
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT
- ClinicalTrials.gov ID
- NCT05207267
- Acronym / sponsor ID
- Ling-driving pressure
- Conditions
- ARDS
- Keywords
- ARDS, ventilation and perfusion matching, ventilation inhomogeneity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Jan 2022 (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.
A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.
Detailed description
Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).
Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2).
Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase，the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testing arm | Experimental | Device: driving pressure guided tidal volumeventilated with different VT using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 18 years old
- admitted to intensive care unit with a moderate to severe ARDS
- invasive mechanical ventilation
Key exclusion criteria (6 listed)
- contraindications for prone position ventilation
- Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
- New York Heart Association class above II
- gave written or witnessed verbal informed consent.
- Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
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 |
|---|---|---|
| driving pressure guided tidal volumeVolume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. | Device | testing arm |
Primary outcome
regional compliance using EIT
Time frame: Day 1
regional compliance using EIT
regional ventilation
Time frame: Day 1
regional ventilation using EIT
regional perfusion
Time frame: Day 1
regional perfusion using EIT
Region-ventilation-delay
Time frame: Day 1
Region-ventilation-delay using EIT
driving pressure
Time frame: Day 3
measurement as one index of respiratory compliance
the number of regional lung ventilation
Time frame: Day 3
regional ventilation measuring by EIT
the number of regional lung perfusion
Time frame: Day 3
regional perfusion measuring by EIT
the number of region-ventilation-delay (RVD)
Time frame: Day 3
the RVD measuring by EIT
9 secondary outcomes
Value of ventilation-perfusion (V/Q) mismatch
Time frame: Day 1
Value of ventilation-perfusion (V/Q) mismatch
Time frame: Day 3
Value of ventilation-perfusion (V/Q) mismatch
Time frame: Day 7
The Global Inhomogeneity (GI) index
Time frame: Day 1
The Global Inhomogeneity (GI) index
Time frame: Day 3
The Global Inhomogeneity (GI) index
Time frame: Day 7
Blood gas
Time frame: Day 1
Ventilation free day
Time frame: Day 28
28 day mortality
Time frame: Day 28
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 24 Aug 2023.
- Derived from this study: PubMed 38012731Yuan X, Zhao Z, Chao Y, Chen D, Chen H, Zhang R, Liu S, Xie J, Yang Y, Qiu H, Heunks L, Liu L. Effects of early versus delayed application of prone position on ventilation-perfusion mismatch in patients with acute respiratory distress syndrome: a prospective observational study. Crit Care. 2023 Nov 27;27(1):462. doi: 10.1186/s13054-023-04749-3.
- Individual participant dataSharing planned: Yes. by email
Related trials for ARDS
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Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
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Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
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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.
Ling Liu study director
Zhongda Hospital, School of Medicine, Southeast Univerty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing driving pressure guided tidal volume in people with 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 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 24 Aug 2023. 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?
regional compliance using EIT (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207267, which also lists 1 linked publication.
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 24 Aug 2023.