Acute Hypoxemic Respiratory FailureSWITCH-SAFENCT06438198
Early Switch From Controlled to Assisted Ventilation
A study of Acute Hypoxemic Respiratory Failure and Mechanical Ventilation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2024to 12 Sep 2026
- 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
- 18 years old
- Written informed consent from a legal representative
- Mechanical ventilation via an endotracheal tube
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
- Under continuous sedation with or without paralysis
Who cannot join
- Expected mechanical ventilation duration of <48 hours
- Pure chronic obstructive pulmonary disease exacerbation
- Pre-existent respiratory muscle disease
- Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
- Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
- Known pregnancy
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation
The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio > 200 mmHg.
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
Read the detailed description
A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.
Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio > 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
- Being tested
- Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
- Keywords
- Electrical Impedance Tomography, Esophageal manometry, Controlled Mechanical Ventilation, Assisted Mechanical Ventilation, Respiratory Monitoring
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHgOther
A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio > 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated adults | Experimental | Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio > 200 mmHg.
Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure. Receives: Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional lung stress
The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
Measured: 72 hours
Secondary outcomes (11)
Electrical Impedance Tomography (EIT) parameters
Change in EIT parameters after transition from controlled to assisted ventilation (%)
Measured: 72 hours
Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch
Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan
Measured: 30 minutes
Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch
Ventilation/perfusion mismatch during controlled ventilation measured with EIT
Measured: 30 minutes
Respiratory mechanics
Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)
Measured: 72 hours
Breathing effort
Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).
Measured: 72 hours
Patient-ventilator asynchrony
Percentage of asynchronous breaths during assisted ventilation
Measured: 72 hours
Gas exchange
Change in gas exchange after transition from controlled to assisted ventilation (%)
Measured: 72 hours
Hemodynamics
Change in hemodynamics after transition from controlled to assisted ventilation (%)
Measured: 72 hours
Blood inflammatory biomarkers
Blood biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
Measured: 72 hours
Breath condensate inflammatory biomarkers
Swivel-derived exhaled-breath condensate biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
Measured: 72 hours
Ventilator-free days
Ventilator-free days at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Sep 2024
- Primary completion12 Sep 2026
- Study completion12 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemijn Jonkman, Erasmus Medical Center
- Investigators
- Annemijn Jonkman, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438198
- Sponsor's protocol ID
- MEC-2024-0011
- Acronym
- SWITCH-SAFE
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation
- ClinicalTrials.gov ID
- NCT06438198
- Acronym / sponsor ID
- SWITCH-SAFE / MEC-2024-0011
- Keywords
- Electrical Impedance Tomography, Esophageal manometry, Controlled Mechanical Ventilation, Assisted Mechanical Ventilation, Respiratory Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 12 Sep 2026 (actual)
- Study completion
- 12 Sep 2026 (actual)
- First posted
- 31 May 2024 (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 goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio > 200 mmHg.
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
Detailed description
A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.
Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio > 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated adults | Experimental | Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHgSwitch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio > 200 mmHg. Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old
- Written informed consent from a legal representative
- Mechanical ventilation via an endotracheal tube
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
- Under continuous sedation with or without paralysis
Key exclusion criteria (7 listed)
- Expected mechanical ventilation duration of <48 hours
- Pure chronic obstructive pulmonary disease exacerbation
- Pre-existent respiratory muscle disease
- Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
- Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
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 |
|---|---|---|
| Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHgA pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio > 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours. | Other | Mechanically ventilated adults |
Primary outcome
Regional lung stress
Time frame: 72 hours
The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
11 secondary outcomes
Electrical Impedance Tomography (EIT) parameters
Time frame: 72 hours
Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch
Time frame: 30 minutes
Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch
Time frame: 30 minutes
Respiratory mechanics
Time frame: 72 hours
Breathing effort
Time frame: 72 hours
Patient-ventilator asynchrony
Time frame: 72 hours
Gas exchange
Time frame: 72 hours
Hemodynamics
Time frame: 72 hours
Blood inflammatory biomarkers
Time frame: 72 hours
Breath condensate inflammatory biomarkers
Time frame: 72 hours
Ventilator-free days
Time frame: 28 days
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 16 Sep 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. This study is not recruiting at the moment.
Annemijn Jonkman, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Hypoxemic Respiratory Failure and Mechanical Ventilation, run by Erasmus Medical Center at 1 site in Netherlands.
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 7 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 16 Sep 2026. 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 Netherlands. 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 lung stress (time frame: 72 hours). 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 16 Sep 2026.