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NCT Number: NCT06438198

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, Netherlands

Location status: Recruiting

Location contact

Annemijn Jonkman, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg

Other

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 outcomes

  1. 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).

Secondary outcomes

  1. Electrical Impedance Tomography (EIT) parameters

    Time frame: 72 hours

    Change in EIT parameters after transition from controlled to assisted ventilation (%)

  2. Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch

    Time frame: 30 minutes

    Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan

  3. Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch

    Time frame: 30 minutes

    Ventilation/perfusion mismatch during controlled ventilation measured with EIT

  4. Respiratory mechanics

    Time frame: 72 hours

    Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)

  5. Breathing effort

    Time frame: 72 hours

    Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).

  6. Patient-ventilator asynchrony

    Time frame: 72 hours

    Percentage of asynchronous breaths during assisted ventilation

  7. Gas exchange

    Time frame: 72 hours

    Change in gas exchange after transition from controlled to assisted ventilation (%)

  8. Hemodynamics

    Time frame: 72 hours

    Change in hemodynamics after transition from controlled to assisted ventilation (%)

  9. Blood inflammatory biomarkers

    Time frame: 72 hours

    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 (%)

  10. Breath condensate inflammatory biomarkers

    Time frame: 72 hours

    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 (%)

  11. Ventilator-free days

    Time frame: 28 days

    Ventilator-free days at day 28

Study contacts

Contact information is provided by the study sponsor or research team.

Annemijn Jonkman, PhD

CONTACT

[email protected]

+3110-7035142

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: SWITCH-SAFE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 31, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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