Clinical trial NCT06438198: Early Switch from Controlled to Assisted Ventilation
Official title: Unraveling the (patho)physiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Mechanical Ventilation
Keywords: Electrical Impedance Tomography
Esophageal manometry
Controlled Mechanical Ventilation
Assisted Mechanical Ventilation
Respiratory Monitoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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).

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.

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

Primary outcomes:
measure: Regional lung stress
timeFrame: 72 hours
Secondary outcomes:
measure: Electrical Impedance Tomography (EIT) parameters
timeFrame: 72 hours
measure: Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch
timeFrame: 30 minutes
measure: Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch
timeFrame: 30 minutes
measure: Respiratory mechanics
timeFrame: 72 hours
measure: Breathing effort
timeFrame: 72 hours
measure: Patient-ventilator asynchrony
timeFrame: 72 hours
measure: Gas exchange
timeFrame: 72 hours
measure: Hemodynamics
timeFrame: 72 hours
measure: Blood inflammatory biomarkers
timeFrame: 72 hours
measure: Breath condensate inflammatory biomarkers
timeFrame: 72 hours
measure: Ventilator-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Annemijn Jonkman, PhD
role: PRINCIPAL_INVESTIGATOR
References: