Assessing lung recruitment in ARDS patients using electrical impedance tomography
RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.
This study is testing if a new method using electrical signals can help doctors see how well the lungs of patients with ARDS can be opened up for better breathing while they are on a ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 171 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 4 sites (São Paulo and 3 other locations) |
| Trial ID | NCT04460859 on ClinicalTrials.gov |
What this trial studies
The RECRUIT study is a multinational observational study that aims to evaluate the feasibility of using electrical impedance tomography (EIT) to measure lung recruitment potential in patients with Acute Respiratory Distress Syndrome (ARDS) who are mechanically ventilated. This single-day study involves specific lung recruitment maneuvers to gather data on how well patients' lungs can be recruited for better oxygenation. By analyzing the responses to these maneuvers, the study seeks to develop personalized methods for optimizing positive end-expiratory pressure (PEEP) settings in real-time. The ultimate goal is to minimize risks associated with inadequate mechanical ventilation in ARDS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are intubated patients diagnosed with moderate to severe ARDS, characterized by a PaO2/FiO2 ratio of 200 mmHg or less.
Not a fit: Patients who are under 18 years old, have hemodynamic instability, or have contraindications to EIT monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized ventilation strategies that enhance oxygenation and potentially increase survival rates in ARDS patients.
How similar studies have performed: While the use of EIT in this context is relatively novel, previous studies have shown promise in using similar techniques for assessing lung function and recruitment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg) * Under continuous sedation with or without paralysis Exclusion Criteria: * Age \<18 years * Bronchopleural fistula * Pure COPD exacerbation * Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement) * Hemodynamic instability (Systolic BP \< 75 mmHg or MAP \< 60 mmHg despite vasopressors and/or heart rate \< 55 bpm) * Attending physician deems the transient application of high airway pressures to be unsafe
Where this trial is running
São Paulo and 3 other locations
- Faculdade de Medicina da University São Paulo — São Paulo, Brazil (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_recruiting)
- Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Laurent Brochard, MD — Unity Health Toronto
- Study coordinator: Laurent Brochard, MD
- Email: Laurent.Brochard@unityhealth.to
- Phone: 416-864-5686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.