Measuring esophageal pressure during one-lung ventilation in surgery
An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation
This study is testing if measuring pressure in the esophagus during one-lung ventilation can help doctors understand how well the lung is collapsing in patients having non-cardiac chest surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04725318 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility and validity of esophageal pressure measurements during one-lung ventilation in patients undergoing non-cardiac intrathoracic surgery. The study will involve measuring esophageal pressure using a balloon catheter and comparing these measurements to lung collapse estimated through Electrical Impedance Tomography (EIT). Patients will undergo a series of pressure recordings before, during, and after the initiation of one-lung ventilation while positioned for surgery. The goal is to establish a correlation between esophageal pressure and lung collapse during a positive end-expiratory pressure trial.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing non-cardiac intrathoracic surgery requiring one-lung ventilation.
Not a fit: Patients with COPD, active respiratory infections, or those who have had prior lung or esophageal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of ventilation strategies during thoracic surgeries, enhancing patient safety and outcomes.
How similar studies have performed: While the approach of measuring esophageal pressure during one-lung ventilation is not widely established, similar studies using EIT have shown promise in improving ventilation management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients undergoing non-cardiac surgery with OLV Exclusion Criteria: * COPD * Active respiratory infection * Prior lung resection * Prior esophageal/gastric surgery * Esophageal varices * Patients under effective anticoagulation at time of surgery * Pacemaker/ICD * Pregnancy * Inability to give written informed consent
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Maximilian S Schaefer, MD
- Email: msschaef@bidmc.harvard.edu
- Phone: 317 306 3216
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.