Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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