RecruitingNot ApplicableNCT06438198

Early Switch from Controlled to Assisted Ventilation

Unraveling the (patho)physiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation


Sponsor

Erasmus Medical Center

Enrollment

20 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

OTHERPre-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.


Locations(1)

Erasmus MC

Rotterdam, Netherlands

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NCT06438198


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