Monitoring breathing effort in patients on mechanical ventilation
Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure
This study is testing a new way to measure how hard patients on mechanical ventilation are working to breathe, to see if it can help them recover better after struggling to breathe on their own.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Italiano de Buenos Aires Academic / other |
| Locations | 4 sites (Buenos Aires and 3 other locations) |
| Trial ID | NCT06040138 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a non-invasive method for measuring breathing effort in patients undergoing mechanical ventilation, particularly those experiencing prolonged weaning. The researchers will utilize airway occlusion pressure to estimate the magnitude of respiratory effort and program ventilator assistance accordingly. By focusing on diaphragmatic protection strategies, the study seeks to maintain muscular effort within an optimal range, thereby improving patient outcomes. The study will include patients who have failed multiple spontaneous breathing trials and have an esophageal balloon placed for accurate measurement.
Who should consider this trial
Good fit: Ideal candidates for this study are patients on mechanical ventilation who have failed three or more spontaneous breathing trials and are hemodynamically stable.
Not a fit: Patients under 18 years old, pregnant women, or those with a do-not-resuscitate order or poor short-term prognosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of patients with respiratory failure by improving weaning strategies and reducing complications associated with prolonged mechanical ventilation.
How similar studies have performed: While the approach of using airway occlusion pressure is validated, the specific methodology of this study is novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mechanical ventilation, who failed 3 or more spontaneous breathing trials * Esophageal balloon placed * Who can trigger the ventilator * With hemodynamic stability * with P/F ratio above 150 Exclusion Criteria: * under 18 years old of age * pregnancy * do not resuscitate order or expected poor short term prognosis * refuse to sign the informed consent
Where this trial is running
Buenos Aires and 3 other locations
- Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" — Buenos Aires, Argentina (Recruiting)
- Hospital Británico — Buenos Aires, Argentina (Recruiting)
- Hospital Italiano de Buenos Aires — Buenos Aires, Argentina (Recruiting)
- Sanatorio Anchorena San Martín — Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Emilio Steinberg, RT — Hospital Italiano
- Study coordinator: Emilio Steinberg, RT
- Email: emilio.steinberg@hospitalitaliano.org.ar
- Phone: +11 64977663
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.