Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

Respiratory failure has historically been one of the most important causes for admittance of patients to the critical care unit. This problem was the most important reason during the COVID-19 pandemic. Following the evolution of the physiology of the lung has therefore been the number one concern during these challenging times in the intensive care unit (ICU). Respiratory oscillometry (RO) identifies the lung impedance by applying small pressure oscillations onto the breathing or ventilation. Information about the respiratory mechanics can be extracted out of this impedance, including the resistance (R) and compliance (C) of the lung. The VUB developed a robust, patient safe RO measurement protocol that delivers high quality measurements with the least possible interference with the patient's breathing/ventilation. The technique challenges current state-of-the-art techniques also aiming at identifying R and C of the respiratory system (not exclusively RO). The RO measurement protocol is in line with the technical standards of the ERS (European Respiratory Society) and has been successfully and safely tested on emulators and some parts on test subjects. The clinical investigation aims at a powered equivalence investigation between the RO measurement protocol and a standard of care dynamic compliance estimate on invasive ventilated patients. As secondary objectives, the feasibility of the RO techniques will be investigated during pressure support ventilation and the RO estimates will also be compared with other accepted respiratory mechanics estimation tools. To enable the investigation, a RO algorithm is developed, and a RO measurement extension is implemented in the DemcAir® ventilation system of Demcon. This was a fully tested ventilator that received a CE mark under the previous MDD regulation. However, Demcon, which produces ventilator parts for other commercial partners, removed the label to avoid competition with their partners. The ventilator will only execute the protocol on demand and save the data on an USB stick available in the ventilator. At any time, the RO measurement procedure can be stopped, and the ventilator will return to its initial ventilation. The USB stick is used to transport the data to a separate (VUB) laptop where the data processing is done.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

intubation

Controlled ventilation with an intention to continue controlled ventilation for the following 4 hours.

Richmond agitation sedation scale of -4 or less

Hemodynamically stable patient with either

Disqualifiers

assist ventilation

Ventilator asynchronies

Intermittent spontaneous breathing

nitric oxide therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • compliance measurement

    Diagnostic test

    compliance can be measured by analyzing pressure volume curves generated through different methods

Treatment groups

21 Participants
are divided into 4 treatment groups
Group A: ROELEC PROTOCOLExperimental treatment 1 intervention
Group B: dynamic P/V curvesActive comparator 1 intervention
Group C: low flow P/V curvesOther 1 intervention
Group D: SOTAOther 1 intervention

Trial outcomes

Primary outcomes

1

compliance

compliance of the lung expressed in "ml/cmH20 "

Time frame
Twice a day with at least 4hour interval, during 1 hour, compliance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve

Secondary outcomes

1

resistance

resistance of the lung expressed in cmH20/L/sec

Time frame
Twice a day with at least 4hour interval, during 1 hour, resistance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
2

impedance

lung impedance expressed in Ohm

Time frame
Twice a day with at least 4hour interval, during 1 hour, impedance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve

Other outcomes

Sponsors and contacts

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