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

NCT06483529 | Recruiting DMC

• 1 other identifier: EC-2023-188-MDR
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator Lung

Keywords

oscillometry; intensive care unit; intubated patients; compliance; resistance; impedance

Outcome Measures

Primary Outcomes (1)

• compliance

  compliance of the lung expressed in "ml/cmH20 "

  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 (2)

• resistance

  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

• impedance

  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

Study Arms (4)

ROELEC PROTOCOL

EXPERIMENTAL

ROELEC measurements consist of the application of a sine or multisine excitation pressure signal superimposed on the ventilation signal. The novelties are in the smart design of the excitation signal, not the way it is applied to the patient.

Diagnostic Test: compliance measurement

dynamic P/V curves

ACTIVE COMPARATOR

dynamic ventilatory pressure volume curves generated during the standard ventilation settings

Diagnostic Test: compliance measurement

low flow P/V curves

OTHER

static ventilatory pressure volume curves will be generated during the procedure to assure that the patients ventilation is between the lower inflection point and the higher inflection point. this P/V curves will also be analysed but will not be included in the primary endpoint analysis

Diagnostic Test: compliance measurement

SOTA

OTHER

Standard of care oscillometry protocol will also generate low flow P/V curves but will not be included in the primary endpoint analysis

Diagnostic Test: compliance measurement

Interventions

compliance measurement DIAGNOSTIC_TEST

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

ROELEC PROTOCOL; SOTA; dynamic P/V curves; low flow P/V curves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• unchanged vasopressor dose administration for at least 60 minutes before the start of the measurements
• no vasopressor need and no vasopressor initiated within 60 minutes of measurements
• No planned intervention in the coming 2 hours
• Survival for at least 48 hours
• Protective ventilation (inspired oxygen concentration≤60%, plateau pressure ≤30 cmH2O , driving pressure≤ 15cmH2O)
• PEEP (Positive End Expiratory Pressure) ≤10

You may not qualify if:

• assist ventilation
• Ventilator asynchronies
• Intermittent spontaneous breathing
• nitric oxide therapy
• presence of an extra corporeal membrane oxygenation device
• Ventilation is not possible within the lower and upper inflection point of the low flow pressure volume curve.
• Unstable right heart failure
• Unstable lung embolism
• Standard of care without Sedline® or invasive arterial catheter
• Do not reanimate code of 2, 3 or 4
• Subjects who are healthy, minors, pregnant women, patients in emergency situation
• Outside the age range 18 to 84 years

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussel Hoofstedelijk Gewest, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• joop jonckheer, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

joop Jonckheer, MD, PhD

CONTACT

028012679; joop.jonckheer@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective equivalence study with a two-arm crossover design - explorative pilot study

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: July 3, 2024
• Study Start: September 18, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: after the most important manuscript(s) will be published, data will be shared. however upon request for review of the manuscript data can be shared.
• Access Criteria: after the most important manuscript(s) will be published, data will be shared. however upon request for review of the manuscript data can be shared.

Locations

BE (1)