Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection

Deep Breeze200 enrolled

Overview

The primary purpose of the study is to investigate the use of VRI to guide the selection of patients for lung surgery. Perfusion scintigraphy is the current method to assess the fractional contribution of lung function of the remaining lung. The hypothesis is that VRI can determine quantitative postoperative lung function equally accurately as a quantitative perfusion scan.

Primarily, VRI will be compared to perfusion (Q) scan by predicted post-operative (ppo) FEV1 and DLCO as predicted by VRI versus as predicted by Q scan. Secondary, the ppo as predicted by each test will be compared with the actual FEV1 and DLCO at 3 months post-operative; If these two methods provide similar results, VRI will be deemed an acceptable alternative to Q scan for determining patient selection for lung resection. Finally, the patient outcomes (30 day mortality and pulmonary complications) for those patients falling within guideline parameters using the VRI measurement will be analyzed to see if using VRI in clinical practice would indeed allow prediction of satisfactory results (similar to literature benchmarks).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Lung Cancer

Interventions

Lung resection surgeryPROCEDURE

The study is designed in a way that will not alter the surgeon's decision based on routine assessment of candidates for resection (lobectomy or greater). Namely, the VRI data will be gathered prospectively; however, the analyses using VRI data will be performed retrospectively.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to read, understand, and provide written Informed Consent; 2. Age range of 18-90 years; 3. Potential candidate for at least lobectomy due to lung cancer or other intrathoracic malignancy (either suspected or proven by biopsy). Both open and minimally invasive (thoracoscopic) resections are acceptable. 4. BMI \> 19. Exclusion Criteria: 1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); 2. There should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings; 3. Hirsutism unless patient is willing to have back shaved; 4. Potentially contagious skin lesion on the back; 5. Giant bulla (more than 1/3 of the hemithorax or \>10cm) 6. Pregnant women

Locations (6)

Yale University School of Medicine

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Boston Medical Center, Boston University

Boston, Massachusetts, United States

Mt. Sinai School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan

Time frame: Prior to surgery

Secondary Outcomes

Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative

Time frame: 3 months after surgery

Data from ClinicalTrials.gov

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