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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05714033

Collaborator

(none)

Enrollment

Location

Arms

133.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Lung	Procedure: Ventilatory Strategy To Prevent Atelectasis Procedure: Lateral Decubitus Strategy (LADS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 30, 2023

Anticipated Primary Completion Date :

Sep 14, 2032

Anticipated Study Completion Date :

Sep 14, 2034

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy	Procedure: Ventilatory Strategy To Prevent Atelectasis Given
Experimental: Group 2 Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.	Procedure: Lateral Decubitus Strategy (LADS) Given

Arm

Intervention/Treatment

Experimental: Group 1

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

Procedure: Ventilatory Strategy To Prevent Atelectasis

Given

Experimental: Group 2

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

Procedure: Lateral Decubitus Strategy (LADS)

Given

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [through study completion; an average of 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Lung bullae > 5 cm
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.
Patient with active COVID pneumonia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Roberto Casal, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M D Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05714033

Other Study ID Numbers:

2022-0756
NCI-2023-00783

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Feb 6, 2023