Thopaz+ measurement of persistent air leaks after lung surgery
Utility of the Thopaz+ System in Evaluating Persistent Air Leaks
Beth Israel Deaconess Medical Center · NCT07105436
This pilot will test whether connecting the Thopaz+ device to chest tubes can help doctors decide if endobronchial valves will fix persistent air leaks in hospitalized adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07105436 on ClinicalTrials.gov |
What this trial studies
This is a prospective, controlled pilot trial enrolling adult inpatients with persistent air leaks of at least five days who are undergoing bronchoscopy as part of their care. The Thopaz+ digital drainage system will be attached to patients' chest tubes to capture objective, quantitative air-leak volume and flow data during bronchoscopic maneuvers. Those data will be combined with standard bronchoscopic localization techniques (including distal airway occlusion and pressure/flow measurements) to guide decisions about endobronchial valve placement or bronchial blood patch. Outcomes will include the usefulness of quantitative leak measurements for localization, procedural decision-making, and clinical endpoints such as chest-tube duration and hospital length of stay.
Who should consider this trial
Good fit: Hospitalized adults aged 18 or older with a persistent air leak lasting at least five days, who are undergoing bronchoscopy for PAL management and can give informed consent are eligible.
Not a fit: Patients who are candidates for surgical repair, have contraindications to bronchoscopy or EBV placement, are pregnant, or cannot tolerate general anesthesia are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could standardize localization of air leaks, speed appropriate valve placement, and shorten chest-tube duration and hospital stays.
How similar studies have performed: Digital drainage systems and balloon-occlusion localization have been used previously to support decision-making, but using Thopaz+ volume quantification specifically to guide endobronchial valve placement is a novel, pilot application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Hospitalized with a persistent air leak (PAL) lasting ≥5 days despite continuous chest tube drainage. * Undergoing bronchoscopy as part of clinical care for PAL management. * Able and willing to provide written informed consent Exclusion Criteria: * Contraindications to bronchoscopy or EBV placement. * Pregnancy. * Inability to tolerate general anesthesia.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Kai Swenson, MD
- Email: BIDMC-IPResearchTeam@bidmc.harvard.edu
- Phone: 617-632-8386
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.
Conditions: Persistent Air Leaks, Chest Tube, Waterseal, Thopaz+