Comparing two strategies to prevent lung collapse during robotic bronchoscopy

A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)

This study is testing if a new way of positioning patients during robotic bronchoscopy can better prevent lung collapse in adults with lung nodules compared to the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05714033 on ClinicalTrials.gov

What this trial studies

This trial aims to determine whether a lateral decubitus strategy (LADS) is more effective than a ventilatory strategy to prevent atelectasis during robotic bronchoscopy for lung lesions. The study will compare the incidence of atelectasis, diagnostic yield, and complications associated with each strategy. It will involve adult patients undergoing bronchoscopy for lung nodules, with a focus on those located in specific bronchial segments. The trial will also assess clinical workflow improvements and diagnostic accuracy for malignancy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with lung nodules up to 3 cm in diameter located in specified bronchial segments, undergoing robotic bronchoscopy for suspected malignancy.

Not a fit: Patients with prior lung consolidation, larger lung masses, or those with specific respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of robotic bronchoscopy, leading to better diagnostic outcomes for patients with lung nodules.

How similar studies have performed: While the specific strategies being compared are novel, similar approaches in optimizing bronchoscopy techniques have shown promise in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
2. Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10. Greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body.
3. Chest CT performed \< 45 days prior to bronchoscopy.
4. Voluntary informed consent to participate in the study.

Exclusion Criteria:

1. Patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent CT
2. Lesions outside of the designated lung areas defined as inclusion criteria.
3. Known pregnancy
4. Vulnerable population
5. Ascites
6. Known diaphragmatic paralysis
7. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted
8. History of primary or secondary spontaneous pneumothorax
9. Lung bullae \> 5 cm
10. Patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion.
11. Patient with active COVID pneumonia.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Roberto Casal, MD — M.D. Anderson Cancer Center
• Study coordinator: Roberto Casal, MD

Conditions Pulmonary; Lung