Trials / Active Not Recruiting
Active Not RecruitingNCT05714033
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.
Detailed description
Primary Objective: To compare the proportion of patients developing target-obscuring atelectasis when using a lateral decubitus strategy (LADS) vs using a ventilatory strategy to prevent atelectasis (VESPA) during robotic bronchoscopy for posteriorly-located peripheral lung lesions. Secondary Objectives: * To compare the proportion of patients with atelectasis in the target lobe in VESPA vs. LADS during robotic bronchoscopy. * To compare the proportion of patients with atelectasis obscuring 100%, 50% or more, and less than 50% of the target during robotic bronchoscopy using LADS vs. VESPA. * To compare the proportion of patients in whom a biopsy sample was not taken due to atelectasis using LADS vs. VESPA. * To compare the diagnostic yield using LADS vs. VESPA. * To compare the proportion of tool in lesion (TIL) using LADS vs. VESPA. * To compare the diagnostic accuracy (sensitivity and specificity) for malignancy using LADS vs. VESPA. * To compare the proportion of LADS-induced vs. VESPA-induced complications. * To compare the proportion of bronchoscopy-induced complications in LADS vs. VESPA. * To compare the accuracy of 3D-2D image registration using LADS vs. VESPA. * To compare clinical workflow in robotic bronchoscopy with VESPA and LADS strategies to identify potential improvements in workflow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ventilatory Strategy To Prevent Atelectasis | Given |
| PROCEDURE | Lateral Decubitus Strategy (LADS) | Given |
Timeline
- Start date
- 2023-02-10
- Primary completion
- 2032-09-14
- Completion
- 2032-09-14
- First posted
- 2023-02-06
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05714033. Inclusion in this directory is not an endorsement.