Active — Not RecruitingNot Applicable

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

United States62 participantsStarted 2023-02-10

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
✓. 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.
✓. Chest CT performed \< 45 days prior to bronchoscopy.
✓. Voluntary informed consent to participate in the study.

✕. Patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent CT
✕. Lesions outside of the designated lung areas defined as inclusion criteria.
✕. Known pregnancy
✕. Vulnerable population
✕. Ascites
✕. Known diaphragmatic paralysis
✕. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted
✕. History of primary or secondary spontaneous pneumothorax

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Timeframe: through study completion; an average of 1 year.

NCT IDNCT05714033

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-09-14

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
✓. 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.
✓. Chest CT performed \< 45 days prior to bronchoscopy.
✓. Voluntary informed consent to participate in the study.

✕. Patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent CT
✕. Lesions outside of the designated lung areas defined as inclusion criteria.
✕. Known pregnancy
✕. Vulnerable population
✕. Ascites
✕. Known diaphragmatic paralysis
✕. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted
✕. History of primary or secondary spontaneous pneumothorax