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

Description

To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.

Conditions

Pulmonary, Lung

Study Overview

Study Details

Study overview

To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.

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

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

Condition
Pulmonary
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \< 4 weeks prior to bronchoscopy.
  • 4. Voluntary informed consent to participate in the study.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Roberto Casal, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2032-09-14