Early Switch From Controlled to Assisted Ventilation

Mechanical Ventilation Clinical Trial

— SWITCH-SAFE  

Official title:

Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438198
• Other study ID #: MEC-2024-0011
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Mechanical Ventilation
• Respiratory Insufficiency

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