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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2032-09-14

Brief Summary

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

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Detailed Description

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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

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Pulmonary Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy

Group Type EXPERIMENTAL

Ventilatory Strategy To Prevent Atelectasis

Intervention Type PROCEDURE

Given

Group 2

Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.

Group Type EXPERIMENTAL

Lateral Decubitus Strategy (LADS)

Intervention Type PROCEDURE

Given

Interventions

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Ventilatory Strategy To Prevent Atelectasis

Given

Intervention Type PROCEDURE

Lateral Decubitus Strategy (LADS)

Given

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.