Acute Respiratory Distress Syndrome (ARDS)SWITCH-ARDSNCT07907276
Early Switch in Moderate ARDS
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by University of Thessaly.
Trial summary
The optimal timing for transition from controlled to assisted mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) remains uncertain. Excessive spontaneous respiratory effort may promote injurious transpulmonary pressure swings and heterogeneous regional ventilation, whereas unnecessary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with ARDS of severe to moderate severity (100<PaO2/FiO2<200 mmHg).
Who may be able to join
- Age ≥18 years
- Endotracheally intubated and receiving invasive mechanical ventilation
- Meets diagnostic criteria for acute respiratory distress syndrome
- PaO₂/FiO₂ ratio >100 and ≤200 mmHg
- Receiving controlled mechanical ventilation immediately before the transition trial
Who cannot join
- Implanted electrical cardiac or other device incompatible with electrical impedance tomography
- Thoracic drains, extensive dressings, or other factors preventing appropriate EIT belt placement
- Contraindication to placement of an esophageal balloon catheter
- Active neuromuscular blockade at initiation of the transition trial
- Significant hemodynamic instability
- Any clinical condition for which reduction of sedation or transition to assisted ventilation is considered unsafe by the treating physician
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Switch to Assisted Ventilation in Patients With Moderate ARDS: a Physiological Study
The optimal timing for transition from controlled to assisted mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) remains uncertain. Excessive spontaneous respiratory effort may promote injurious transpulmonary pressure swings and heterogeneous regional ventilation, whereas unnecessary prolongation of controlled ventilation may increase sedation exposure and diaphragmatic dysfunction.
This prospective, single-center physiological interventional study will enroll mechanically ventilated adults with ARDS and a PaO₂/FiO₂ ratio >100 and ≤200 mmHg, measured during PEEP=5 cmH2O, who are receiving controlled mechanical ventilation. Participants will undergo a protocolized 30-minute transition from controlled to assisted mechanical ventilation after reduction of sedation sufficient to allow spontaneous respiratory activity.
Respiratory effort and drive, airway and esophageal pressures, respiratory flow, respiratory mechanics, gas exchange, and regional ventilation measured by electrical impedance tomography will be assessed before and during the transition. Participants will subsequently be followed for 48 hours to determine whether assisted ventilation can be maintained without return to fully controlled mechanical ventilation.
Read the detailed description
Participants meeting eligibility criteria will initially remain on their clinically prescribed controlled mechanical ventilation. Sedation will be gradually reduced to permit the reappearance of spontaneous respiratory activity while avoiding clinically significant agitation or patient-ventilator dyssynchrony. Once spontaneous respiratory activity is present, participants will be transitioned to assisted mechanical ventilation. Positive end-expiratory pressure will be maintained at the pre-transition level, which will have been titrated with the use of esophageal manometry so as to achieve an end-expiratory trans-pulmonary pressure above 0 cmH2O, and inspired oxygen fraction will remain unchanged whenever clinically feasible. Inspiratory assistance will be titrated to maintain protective targets: esophageal pressure swings= 3-15 cmH2O (diaphragm protective) and transpulmonary pressure swings < 15-20 cmH2O (lung protective).
The physiological transition trial will last 30 minutes. Continuous recordings of airway pressure, esophageal pressure, respiratory flow, and electrical impedance tomography will be obtained. Respiratory drive will additionally be assessed using airway occlusion pressure at 100 milliseconds (P0.1).
Three prespecified analysis periods will be used: T0, the final 5 minutes during controlled ventilation before transition; T1, the first 5 minutes of assisted ventilation; and T2, minutes 25-30 of assisted ventilation.
Electrical impedance tomography analyses will include regional distribution of tidal ventilation, global inhomogeneity index, end-expiratory lung impedance, ventral-to-dorsal ventilation distribution, center of ventilation, and occurrence or magnitude of pendelluft. Respiratory mechanics analyses will include esophageal pressure swing, pressure-time product of the esophageal pressure, transpulmonary pressure, respiratory system elastance, chest-wall elastance, and lung elastance.
The transition trial will be stopped if prespecified clinical intolerance or safety criteria occur. Participants who do not tolerate the trial will be returned to controlled ventilation according to clinical requirements.
After completion of the 30-minute trial, participants will be followed for 48 hours. Successful transition will be defined as maintenance of assisted mechanical ventilation without the need to return to fully controlled mechanical ventilation during this period.
- Being tested
- Protocolized Transition From Controlled to Assisted Mechanical Ventilation
- Keywords
- pressure support ventilation, acute respiratory distress syndrome, electrical impedance tomography, esophageal pressure, mechanical ventilation, PEEP
- 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.
Protocolized Transition From Controlled to Assisted Mechanical VentilationOther
Participants receiving controlled mechanical ventilation will undergo gradual reduction of sedation to permit spontaneous respiratory activity, followed by a 30-minute transition to assisted mechanical ventilation. PEEP will remain at the pre-transition value and FiO₂ will remain unchanged whenever clinically feasible. Inspiratory assistance will be titrated to maintain tidal volume at approximately 6-8 mL/kg predicted body weight. Physiological measurements will be recorded continuously, and the procedure will be terminated if prespecified intolerance or safety criteria occur.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Protocolized Transition to Assisted Mechanical Ventilation | Not described Receives: Other: Protocolized Transition From Controlled to Assisted Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. We will measure respiratory rate (breaths per minute).
Measured: During the first thirty minutes of assisted ventilation.
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. The measured variables will include the lung elastance, the chest wall elastance and the total respiratory system elastance (all measured in cmH₂O/L).
Measured: During the first thirty minutes of assisted ventilation.
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. The measured variables will include the transpulmonary pressure, which is measured in cmH₂O. During the baseline measurement both statics and dynamics measurements will be calculated, whereas during the assisted phase the investigator will include only the dynamic measurements.
Measured: During the first thirty minutes of assisted ventilation.
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. We will measure tidal volume (mLs).
Measured: During the first thirty minutes of assisted ventilation.
Secondary outcomes (6)
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
The investigator will measure the variation in the global inhomogeneity index derived by using electrical impedance tomography.
Measured: During the first thirty minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
The investigator will measure the end-expiratory lung impedance, EELI, which is measured in ohms.
Measured: During the first 30-minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
The investigator will measure the ventral to dorsal ratio using the electrical impedance tomography.
Measured: During the first 30-minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
The investigator will measure the variation in the pendelluft phenomenon using the impedance amplitude values.
Measured: During the first 30-minutes of assisted ventilation.
Differences in respiratory effort between successful and failed transition to assisted ventilation
The investigator will measure the differences in esophageal pressure swings, ΔPes in cmH₂O, between the beginning of the transition phase and at the final 5 minutes of the 30-minute trial.
Measured: During the first 30-minutes of assisted ventilation.
Differences in respiratory effort between successful and failed transition to assisted ventilation.
The investigator will measure the differences in the esophageal pressure-time product measured in cmH₂O⋅s/min, between the beginning of the transition phase and at the final 5 minutes of the 30-minute trial.
Measured: During the first 30-minutes of assisted ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (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 Syndrome (ARDS)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMOSTHENES MAKRIS, University of Thessaly
- Investigators
- Apostolos - Alkiviadis Menis, MD, PhD, Principal investigator, General University Hospital of Larisa, University of ThessalyMakris, MD, PhD, Study director, General University Hospital of Larisa, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907276
- Sponsor's protocol ID
- SWITCH_MODERATE_ARDS
- Acronym
- SWITCH-ARDS
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Switch to Assisted Ventilation in Patients With Moderate ARDS: a Physiological Study
- ClinicalTrials.gov ID
- NCT07907276
- Acronym / sponsor ID
- SWITCH-ARDS / SWITCH_MODERATE_ARDS
- Keywords
- pressure support ventilation, acute respiratory distress syndrome, electrical impedance tomography, esophageal pressure, mechanical ventilation, PEEP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Oct 2026 (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 optimal timing for transition from controlled to assisted mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) remains uncertain. Excessive spontaneous respiratory effort may promote injurious transpulmonary pressure swings and heterogeneous regional ventilation, whereas unnecessary prolongation of controlled ventilation may increase sedation exposure and diaphragmatic dysfunction.
This prospective, single-center physiological interventional study will enroll mechanically ventilated adults with ARDS and a PaO₂/FiO₂ ratio >100 and ≤200 mmHg, measured during PEEP=5 cmH2O, who are receiving controlled mechanical ventilation. Participants will undergo a protocolized 30-minute transition from controlled to assisted mechanical ventilation after reduction of sedation sufficient to allow spontaneous respiratory activity.
Respiratory effort and drive, airway and esophageal pressures, respiratory flow, respiratory mechanics, gas exchange, and regional ventilation measured by electrical impedance tomography will be assessed before and during the transition. Participants will subsequently be followed for 48 hours to determine whether assisted ventilation can be maintained without return to fully controlled mechanical ventilation.
Detailed description
Participants meeting eligibility criteria will initially remain on their clinically prescribed controlled mechanical ventilation. Sedation will be gradually reduced to permit the reappearance of spontaneous respiratory activity while avoiding clinically significant agitation or patient-ventilator dyssynchrony. Once spontaneous respiratory activity is present, participants will be transitioned to assisted mechanical ventilation. Positive end-expiratory pressure will be maintained at the pre-transition level, which will have been titrated with the use of esophageal manometry so as to achieve an end-expiratory trans-pulmonary pressure above 0 cmH2O, and inspired oxygen fraction will remain unchanged whenever clinically feasible. Inspiratory assistance will be titrated to maintain protective targets: esophageal pressure swings= 3-15 cmH2O (diaphragm protective) and transpulmonary pressure swings < 15-20 cmH2O (lung protective).
The physiological transition trial will last 30 minutes. Continuous recordings of airway pressure, esophageal pressure, respiratory flow, and electrical impedance tomography will be obtained. Respiratory drive will additionally be assessed using airway occlusion pressure at 100 milliseconds (P0.1).
Three prespecified analysis periods will be used: T0, the final 5 minutes during controlled ventilation before transition; T1, the first 5 minutes of assisted ventilation; and T2, minutes 25-30 of assisted ventilation.
Electrical impedance tomography analyses will include regional distribution of tidal ventilation, global inhomogeneity index, end-expiratory lung impedance, ventral-to-dorsal ventilation distribution, center of ventilation, and occurrence or magnitude of pendelluft. Respiratory mechanics analyses will include esophageal pressure swing, pressure-time product of the esophageal pressure, transpulmonary pressure, respiratory system elastance, chest-wall elastance, and lung elastance.
The transition trial will be stopped if prespecified clinical intolerance or safety criteria occur. Participants who do not tolerate the trial will be returned to controlled ventilation according to clinical requirements.
After completion of the 30-minute trial, participants will be followed for 48 hours. Successful transition will be defined as maintenance of assisted mechanical ventilation without the need to return to fully controlled mechanical ventilation during this period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Protocolized Transition to Assisted Mechanical Ventilation | – | Other: Protocolized Transition From Controlled to Assisted Mechanical Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS of severe to moderate severity (100<PaO2/FiO2<200 mmHg).
Key inclusion criteria (5 listed)
- Age ≥18 years
- Endotracheally intubated and receiving invasive mechanical ventilation
- Meets diagnostic criteria for acute respiratory distress syndrome
- PaO₂/FiO₂ ratio >100 and ≤200 mmHg
- Receiving controlled mechanical ventilation immediately before the transition trial
Key exclusion criteria (6 listed)
- Implanted electrical cardiac or other device incompatible with electrical impedance tomography
- Thoracic drains, extensive dressings, or other factors preventing appropriate EIT belt placement
- Contraindication to placement of an esophageal balloon catheter
- Active neuromuscular blockade at initiation of the transition trial
- Significant hemodynamic instability
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 |
|---|---|---|
| Protocolized Transition From Controlled to Assisted Mechanical VentilationParticipants receiving controlled mechanical ventilation will undergo gradual reduction of sedation to permit spontaneous respiratory activity, followed by a 30-minute transition to assisted mechanical ventilation. PEEP will remain at the pre-transition value and FiO₂ will remain unchanged whenever clinically feasible. Inspiratory assistance will be titrated to maintain tidal volume at approximately 6-8 mL/kg predicted body weight. Physiological measurements will be recorded continuously, and the procedure will be terminated if prespecified intolerance or safety criteria occur. | Other | Experimental: Protocolized Transition to Assisted Mechanical Ventilation |
Primary outcome
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
Time frame: During the first thirty minutes of assisted ventilation.
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. We will measure respiratory rate (breaths per minute).
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
Time frame: During the first thirty minutes of assisted ventilation.
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. The measured variables will include the lung elastance, the chest wall elastance and the total respiratory system elastance (all measured in cmH₂O/L).
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
Time frame: During the first thirty minutes of assisted ventilation.
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. The measured variables will include the transpulmonary pressure, which is measured in cmH₂O. During the baseline measurement both statics and dynamics measurements will be calculated, whereas during the assisted phase the investigator will include only the dynamic measurements.
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph
Time frame: During the first thirty minutes of assisted ventilation.
The investigator will measure the respiratory mechanics at baseline, after the first five minutes of assisted ventilation and at 30 minutes of assisted ventilation. We will measure tidal volume (mLs).
6 secondary outcomes
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
Time frame: During the first thirty minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
Time frame: During the first 30-minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
Time frame: During the first 30-minutes of assisted ventilation.
Differences in electrical impedance tomography variables between successful and failed transition to assisted ventilation
Time frame: During the first 30-minutes of assisted ventilation.
Differences in respiratory effort between successful and failed transition to assisted ventilation
Time frame: During the first 30-minutes of assisted ventilation.
Differences in respiratory effort between successful and failed transition to assisted ventilation.
Time frame: During the first 30-minutes of assisted ventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
Apostolos - Alkiviadis Menis, MD, PhD principal investigator
General University Hospital of Larisa, University of Thessaly
Makris, MD, PhD study director
General University Hospital of Larisa, University of Thessaly
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by University of Thessaly.
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 5 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Apostolos - Alkiviadis Menis, MD, PhD (+30 2413501280, menis.ap.alk@proton.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Respiratory Mechanics between succesfull and failed transition using a pneumotachograph (time frame: During the first thirty minutes of assisted ventilation.). The study lists 4 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 30 Oct 2026.