Health TrialsbyHealthPanel

Early Switch from Controlled to Assisted Ventilation

ConditionsAcute Hypoxemic Respiratory FailureMechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Mechanically ventilated adultsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Regional lung stress

The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).

Time frame
72 hours

Secondary outcomes

1

Electrical Impedance Tomography (EIT) parameters

Change in EIT parameters after transition from controlled to assisted ventilation (%)

Time frame
72 hours
2

Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch

Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan

Time frame
30 minutes
3

Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch

Ventilation/perfusion mismatch during controlled ventilation measured with EIT

Time frame
30 minutes
4

Respiratory mechanics

Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now