ARDS (Acute Respiratory Distress Syndrome)DELTANCT04247477
Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS
A study testing Ventilation strategy in people with ARDS (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), run by University Hospital, Angers at 1 site in France.
Trial summary
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit. Two of those strategies are based on electrical impedance tomography (EIT) monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP)
- What is being tested?
- Ventilation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2020to 8 Apr 2021
- 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
- patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis
- PaO2/FiO2 ratio < 150 mmHg
- Patient affiliated to or beneficiary of a health care plan
- Consent obtained from patient's SDM
Who cannot join
- Pneumothorax
- Contraindication to the insertion of a nasogastric tube with an esophageal balloon
- Contraindication to the use of Electrical impedance tomography
- Pregnancy, lactating or parturient woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.
Two of those strategies are based on electrical impedance tomography (EIT) monitoring.
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP), Acute Lung Injury
- Being tested
- Ventilation strategy
- Keywords
- ARDS, EIT, PEEP titration, Mechanical Ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation strategyOther
Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)
| Study group | Role | What they receive |
|---|---|---|
| A-B-A-C | Experimental | Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) - Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) Receives: Other: Ventilation strategy |
| A-C-A-B | Experimental | Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) - Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) Receives: Other: Ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2 (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance!
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Secondary outcomes (12)
Change in PaCO2 (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Plateau pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Positive end expiratory pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Expiratory and inspiratory transpulmonary pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Regional ventilation distribution (%)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Center of ventilation (%)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Overdistension and collapsus (%)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Global and regional end expiratory lung impedance changes (IU)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
End expiratory lung volume (mL)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Blood pressure (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Heart rate (bpm)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Cardiac output (L/min)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Measured: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start22 Sep 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Crossover
- Model description
- We use a crossover sequential model, with all 3 strategies tested in both arms. A reference strategy, based on the Express method (PEEP level adjusted to reach a plateau pressure of 28-30 cmH2O), is applied at the begining of the study and during a wash-out period (between the 2 periods of application of the 2 EIT-based strategies). The 2 EIT-based strategies are applied in a randomized order.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247477
- Sponsor's protocol ID
- 49RC19_0249
- Acronym
- DELTA
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study
- ClinicalTrials.gov ID
- NCT04247477
- Acronym / sponsor ID
- DELTA / 49RC19_0249
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP), Acute Lung Injury
- Keywords
- ARDS, EIT, PEEP titration, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 30 Jan 2020 (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.
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.
Two of those strategies are based on electrical impedance tomography (EIT) monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We use a crossover sequential model, with all 3 strategies tested in both arms. A reference strategy, based on the Express method (PEEP level adjusted to reach a plateau pressure of 28-30 cmH2O), is applied at the begining of the study and during a wash-out period (between the 2 periods of application of the 2 EIT-based strategies). The 2 EIT-based strategies are applied in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| A-B-A-C | Experimental | Other: Ventilation strategyFour consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) - Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) |
| A-C-A-B | Experimental | Other: Ventilation strategyFour consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) - Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis
- PaO2/FiO2 ratio < 150 mmHg
- Patient affiliated to or beneficiary of a health care plan
- Consent obtained from patient's SDM
Key exclusion criteria (4 listed)
- Pneumothorax
- Contraindication to the insertion of a nasogastric tube with an esophageal balloon
- Contraindication to the use of Electrical impedance tomography
- Pregnancy, lactating or parturient woman
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 |
|---|---|---|
| Ventilation strategyPatients are ventilated in randomized order with three different ventilation strategies (A,B and C) | Other | A-B-A-C, A-C-A-B |
Primary outcome
Change in PaO2 (mmHg)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
As it is a physiological study, all the outcomes will be analyzed with the same importance!
12 secondary outcomes
Change in PaCO2 (mmHg)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Plateau pressure (cmH2O)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Positive end expiratory pressure (cmH2O)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Expiratory and inspiratory transpulmonary pressure (cmH2O)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Regional ventilation distribution (%)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Center of ventilation (%)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Overdistension and collapsus (%)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Global and regional end expiratory lung impedance changes (IU)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
End expiratory lung volume (mL)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Blood pressure (mmHg)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Heart rate (bpm)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Cardiac output (L/min)
Time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
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 2 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation strategy in people with ARDS (Acute Respiratory Distress Syndrome) and Electrical Impedance Tomography (EIT), run by University Hospital, Angers at 1 site in France.
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 4 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 2 Aug 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 France. 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?
Change in PaO2 (mmHg) (time frame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes). 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 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.