Actively Recruiting
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique, an Explorative Study
Led by Universitair Ziekenhuis Brussel · Updated on 2024-07-03
21
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Respiratory failure remains a critical reason for admission to intensive care units, especially highlighted during the COVID-19 pandemic. Researchers are evaluating a new respiratory oscillometry (RO) measurement protocol developed by VUB that assesses lung mechanics by applying small pressure oscillations to breathing or ventilation. This study aims to compare this RO protocol with standard care dynamic compliance measurements in patients receiving invasive ventilation. Secondary goals include testing the RO method during pressure support ventilation and comparing its results with other respiratory mechanics tools. The study involves several measurement approaches including ROELEC measurements, dynamic and static ventilatory pressure-volume curves, and standard of care oscillometry protocols. These techniques apply specific pressure signals to the ventilator and analyze lung compliance and resistance. The RO protocol is integrated into the DemcAir a9 ventilation system, which records data on a USB stick for separate analysis. Measurements occur twice daily with at least 4-hour intervals, focusing on lung compliance, resistance, and impedance during different ventilation actions. Participants will be monitored while intubated and invasively ventilated under controlled settings. Data will be collected through multiple respiratory tests over at least 48 hours, ensuring patient stability and safety. The primary outcome is lung compliance measured during the various protocols, with secondary outcomes including resistance and impedance. The ventilator can stop the RO procedure at any time, returning to normal ventilation, and all data processing is done separately from patient care. The study runs until the end of 2024 and recruits adults aged 18 to 84 years who meet specific clinical stability criteria.
CONDITIONS
Brief Title
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intubated patients receiving controlled ventilation with intent to continue for at least 4 hours
- Richmond agitation sedation scale of -4 or less
- Hemodynamically stable with unchanged vasopressor dose for at least 60 minutes or no vasopressor use within 60 minutes before measurements
- No planned interventions in the next 2 hours
- Expected survival of at least 48 hours
- Protective ventilation settings: inspired oxygen concentration 60%, plateau pressure 60 cmH2O, driving pressure 15 cmH2O
- Positive End Expiratory Pressure (PEEP) 10 cmH2O
- Age between 18 and 84 years
You will not qualify if you...
- Patients on assist ventilation
- Presence of ventilator asynchronies
- Intermittent spontaneous breathing
- Receiving nitric oxide therapy
- Use of extracorporeal membrane oxygenation device
- Ventilation outside lower and upper inflection points of low flow pressure-volume curve
- Unstable right heart failure
- Unstable lung embolism
- Standard of care without Sedline�ae or invasive arterial catheter
- Do not resuscitate codes 2, 3, or 4
- Healthy individuals, minors, pregnant women, or emergency patients
- Outside the age range 18 to 84 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated measurements twice a day with at least 4 hour intervals during 1 hour per session
Participants undergo different respiratory mechanics measurements using various pressure volume curve methods including ROELEC protocol, standard of care oscillometry, dynamic, and low flow P/V curves.
Twice daily measurements during ventilation
Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Jette, Brussel Hoofstedelijk Gewest, Belgium, 1090
Actively Recruiting
Research Team
J
joop Jonckheer, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here