Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06438198

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

Led by Erasmus Medical Center · Updated on 2024-10-18

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the physiological effects and possible clinical benefits of switching early from controlled to assisted ventilation in adult patients who are mechanically ventilated due to acute hypoxemic respiratory failure, characterized by a PaO2/FiO2 ratio less than 200 mmHg. This study focuses on how this early switch impacts lung stress and lung function, as there is currently no guidance on the optimal timing for changing ventilation modes in these patients. Participants will be switched from controlled ventilation to assisted ventilation when their PaO2/FiO2 ratio improves to above 200 mmHg. Before the switch, patients will undergo lung imaging and perfusion assessments using electrical impedance tomography and photon-counting CT scans. After the switch, continuous monitoring of lung function, pressure, and breathing effort will take place for up to 72 hours or until the switch is deemed unsuccessful. Success is defined as maintaining assisted ventilation for 72 hours, while failure involves returning to controlled ventilation for more than 2 hours within that period. During the study, participants will be closely monitored through various lung and breathing assessments, including electrical impedance tomography, esophageal and gastric pressure measurements, and respiratory mechanics. Researchers will measure lung stress, ventilation/perfusion mismatch, breathing effort, gas exchange, inflammatory biomarkers, and other respiratory and hemodynamic parameters. The primary outcome is the change in regional lung stress over 72 hours. The study participation spans from initial ventilation mode switch to monitoring for up to 72 hours post-switch, with additional follow-up assessments twice daily until study completion or switch failure.

CONDITIONS

Brief Title

Early Switch from Controlled to Assisted Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Written informed consent from a legal representative
  • Receiving mechanical ventilation via an endotracheal tube
  • Diagnosed with acute hypoxemic respiratory failure with PaO2/FiO2 ratio less than 200 mmHg
  • Under continuous sedation with or without paralysis
Not Eligible

You will not qualify if you...

  • Expected duration of mechanical ventilation less than 48 hours
  • Pure exacerbation of chronic obstructive pulmonary disease
  • Pre-existing respiratory muscle disease
  • Contraindication to electrical impedance tomography monitoring (e.g., pacemaker, burns, or thoracic wounds)
  • Contraindication to oesophageal manometry (e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
  • Known pregnancy
  • Anticipating withdrawal of life support or shift to palliative care as the goal of treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 72 hours post-switch

Participants are switched from controlled to assisted ventilation when their PaO2/FiO2 ratio exceeds 200 mmHg. They will be closely monitored using electrical impedance tomography and pressure measurements from 15 minutes before the switch until 4 hours after, and then twice daily for up to 72 hours or until switch failure.

Continuous monitoring from 15 minutes before switch until 4 hours after, plus twice daily monitoring for up to 72 hours

Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

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Research Team

A

Annemijn Jonkman, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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