Early Switch from Controlled to Assisted Ventilation (SWITCH-SAFE)

October 16, 2024 updated by: Annemijn Jonkman, Erasmus Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
        • Contact:
          • Annemijn Jonkman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanically ventilated adults

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical Impedance Tomography (EIT) parameters
Time Frame: 72 hours
Change in EIT parameters after transition from controlled to assisted ventilation (%)
72 hours
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
30 minutes
Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch
Time Frame: 30 minutes
Ventilation/perfusion mismatch during controlled ventilation measured with EIT
30 minutes
Respiratory mechanics
Time Frame: 72 hours
Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)
72 hours
Breathing effort
Time Frame: 72 hours
Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).
72 hours
Patient-ventilator asynchrony
Time Frame: 72 hours
Percentage of asynchronous breaths during assisted ventilation
72 hours
Gas exchange
Time Frame: 72 hours
Change in gas exchange after transition from controlled to assisted ventilation (%)
72 hours
Hemodynamics
Time Frame: 72 hours
Change in hemodynamics after transition from controlled to assisted ventilation (%)
72 hours
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 (%)
72 hours
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 (%)
72 hours
Ventilator-free days
Time Frame: 28 days
Ventilator-free days at day 28
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Annemijn Jonkman, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2024-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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