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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06438198
Other study ID # MEC-2024-0011
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date May 2026

Study information

Verified date May 2024
Source Erasmus Medical Center
Contact Annemijn Jonkman, PhD
Phone +3110-7035142
Email a.jonkman@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date May 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Regional lung stress The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio). 72 hours
Secondary Electrical Impedance Tomography (EIT) parameters Change in EIT parameters after transition from controlled to assisted ventilation (%) 72 hours
Secondary Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan 30 minutes
Secondary Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch Ventilation/perfusion mismatch during controlled ventilation measured with EIT 30 minutes
Secondary Respiratory mechanics Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O) 72 hours
Secondary Breathing effort Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O). 72 hours
Secondary Patient-ventilator asynchrony Percentage of asynchronous breaths during assisted ventilation 72 hours
Secondary Gas exchange Change in gas exchange after transition from controlled to assisted ventilation (%) 72 hours
Secondary Hemodynamics Change in hemodynamics after transition from controlled to assisted ventilation (%) 72 hours
Secondary Blood inflammatory biomarkers 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
Secondary Breath condensate inflammatory biomarkers 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
Secondary Ventilator-free days Ventilator-free days at day 28 28 days
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