Observing how ventilator settings affect lung pressure during surgery
A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)
This study looks at how different settings on a ventilator during surgery affect lung pressure in patients under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05859672 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effects of different ventilator settings, specifically tidal volume and PEEP, on transpulmonary pressure using an esophageal balloon catheter. It will monitor variations in transpulmonary and intrathoracic pressures during elective surgeries requiring general anesthesia. The study will also explore how changes in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm H2O to 5 cm H2O influence stroke volume variation, which has not been previously examined in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
Not a fit: Patients undergoing planned esophageal surgery, those with significant nasal or esophageal pathology, and individuals unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of mechanical ventilation during surgery, leading to better patient outcomes.
How similar studies have performed: While this approach is novel in examining the correlation between ventilator settings and stroke volume variation, similar studies have shown the importance of monitoring lung pressures during mechanical ventilation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation. * Age ≥ 18 Exclusion Criteria: * Patients undergoing planned esophageal surgery * Patients with significant nasal or esophageal pathology * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Where this trial is running
Sacramento, California
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Neal Fleming, MD, PhD — University of California, Davis
- Study coordinator: Neal Fleming, MD, PhD
- Email: nwfleming@ucdavis.edu
- Phone: 916 734-5046
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.