Acute Respiratory Distress SyndromeEARDSNCT04241874
PEEP and Spontaneous Breathing During ARDS
A study testing Mechanical Ventilation in people with Acute Respiratory Distress Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
- (b) assisted ventilation, as prescribed by the attending physician
- (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion
Who cannot join
- Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS
Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.
Read the detailed description
This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition.
Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.
Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW [kg] = 45.5 + 0.91 [cm of height - 152.4]; male PBW [kg] = 50 + 0.91 [cm of height - 152.4]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt <8 ml/Kg PBW is not achieved.
In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Mechanical Ventilation
- 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.
Mechanical VentilationOther
Respiratory support through mechanical ventilator
| Study group | Role | What they receive |
|---|---|---|
| Low PEEP and full inspiratory synchronization | Experimental | PEEP = 5 cmH2O + clinically selected pressure support (PSVclin) Receives: Other: Mechanical Ventilation |
| High PEEP and full inspiratory synchronization | Experimental | PEEP = 15 cmH2O + clinically selected pressure support (PSVclin) Receives: Other: Mechanical Ventilation |
| Low PEEP and inspiratory desynchronization | Experimental | PEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O) Receives: Other: Mechanical Ventilation |
| High PEEP and inspiratory desynchronization | Experimental | PEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O) Receives: Other: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort
The negative deflection in esophageal pressure during inspiration
Measured: 45 minutes
Secondary outcomes (11)
Oxygenation
Ratio of PaO2 to FiO2
Measured: 45 minutes
Respiratory mechanics
Respiratory mechanics assessed by end-inspiratory occlusion
Measured: 45 minutes
Lung mechanics
Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion
Measured: 45 minutes
Work of breathing
Esopghageal pressure pressure-time product per minute
Measured: 45 minutes
Respiratory rate
Respiratory rate per minute
Measured: 45 minutes
Regional Tidal volume distribution
Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography
Measured: 45 minutes
Alveolar recruitment
Change in end-expiratory lung impedance, assessed by electrical impedance tomography
Measured: 45 minutes
Pendelluft
Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration
Measured: 45 minutes
Carbon dioxide
Blood carbon dioxide, as assessed by arterial blood gas analysis
Measured: 45 minutes
Tidal volume
Average Tidal volume received by the patient
Measured: 45 minutes
Dynamic transpulmonary driving pressure
The average positive swing in transpulmonary driving pressure during tidal breathing
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 May 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Bello, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCSMassimo Antonelli, MD, Study director, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241874
- Sponsor's protocol ID
- EARDS
- Acronym
- EARDS
- Status last verified
- Sep 2022
- First submitted
- 22 Jan 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual patient data will be made available upon a reasonable request
Publications
Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.
PubMed 38295949
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS
- ClinicalTrials.gov ID
- NCT04241874
- Acronym / sponsor ID
- EARDS / EARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 27 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.
Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.
Detailed description
This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition.
Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.
Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW [kg] = 45.5 + 0.91 [cm of height - 152.4]; male PBW [kg] = 50 + 0.91 [cm of height - 152.4]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt <8 ml/Kg PBW is not achieved.
In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low PEEP and full inspiratory synchronization | Experimental | Other: Mechanical VentilationPEEP = 5 cmH2O + clinically selected pressure support (PSVclin) |
| High PEEP and full inspiratory synchronization | Experimental | Other: Mechanical VentilationPEEP = 15 cmH2O + clinically selected pressure support (PSVclin) |
| Low PEEP and inspiratory desynchronization | Experimental | Other: Mechanical VentilationPEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O) |
| High PEEP and inspiratory desynchronization | Experimental | Other: Mechanical VentilationPEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
- (b) assisted ventilation, as prescribed by the attending physician
- (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion
Key exclusion criteria (1 listed)
- Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.
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 |
|---|---|---|
| Mechanical VentilationRespiratory support through mechanical ventilator | Other | High PEEP and full inspiratory synchronization, High PEEP and inspiratory desynchronization, Low PEEP and full inspiratory synchronization, Low PEEP and inspiratory desynchronization |
Primary outcome
Inspiratory effort
Time frame: 45 minutes
The negative deflection in esophageal pressure during inspiration
11 secondary outcomes
Oxygenation
Time frame: 45 minutes
Respiratory mechanics
Time frame: 45 minutes
Lung mechanics
Time frame: 45 minutes
Work of breathing
Time frame: 45 minutes
Respiratory rate
Time frame: 45 minutes
Regional Tidal volume distribution
Time frame: 45 minutes
Alveolar recruitment
Time frame: 45 minutes
Pendelluft
Time frame: 45 minutes
Carbon dioxide
Time frame: 45 minutes
Tidal volume
Time frame: 45 minutes
Dynamic transpulmonary driving pressure
Time frame: 45 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 7 Sep 2022.
- Derived from this study: PubMed 38295949Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.
- Individual participant dataSharing planned: Undecided. Individual patient data will be made available upon a reasonable request
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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.
Giuseppe Bello, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD study director
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation in people with Acute Respiratory Distress Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 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 7 Sep 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 Italy. 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?
Inspiratory effort (time frame: 45 minutes). 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 NCT04241874, 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 7 Sep 2022.