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

Primary Purpose

Pulmonary, Lung

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilatory Strategy To Prevent Atelectasis
Lateral Decubitus Strategy (LADS)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
September 19, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05714033
Brief Title
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
Official Title
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
September 14, 2032 (Anticipated)
Study Completion Date
September 14, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary, Lung

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.
Intervention Type
Procedure
Intervention Name(s)
Ventilatory Strategy To Prevent Atelectasis
Intervention Description
Given
Intervention Type
Procedure
Intervention Name(s)
Lateral Decubitus Strategy (LADS)
Intervention Description
Given
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame
through study completion; an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Casal, MD
Phone
(832) 287-9479
Email
rfcasal@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Casal, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Casal, MD
Phone
832-287-9479
Email
rfcasal@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Roberto Casal, Casal

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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