Early Switch from Controlled to Assisted Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg.
- Who it may be relevant to
- Registry conditions: Acute Hypoxemic Respiratory Failure, Mechanical Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Unraveling the (patho)physiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation
Overview
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.
Interventions
- Other Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
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.
Primary outcome measures
- Regional lung stress [Time frame: 72 hours]
Secondary outcome measures (11)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06438198 · MEC-2024-0011