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

Lung Clinical 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714033
• Other study ID #: 2022-0756
• Secondary ID: NCI-2023-00783
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: September 14, 2032

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Roberto Casal, MD
• Phone: (832) 287-9479
• Email: rfcasal[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 14, 2032
• Est. primary completion date: September 14, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 < 4 weeks prior to bronchoscopy.

4. Voluntary informed consent to participate in the study.

Exclusion Criteria:

1. Patients with prior lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) as seen on most recent CT

2. Lesions outside of the designated lung areas defined as inclusion criteria.

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.

Related Conditions & MeSH terms

• Lung
• Pulmonary Atelectasis

Intervention

Procedure:
• Ventilatory Strategy To Prevent Atelectasis
Given
• Lateral Decubitus Strategy (LADS)
Given

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center