Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT05714033
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-00783 | OTHER | NCI CTRP Clinical Trials Registry | View |