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

NCT05714033 | Active Not Recruiting

• 2 other identifiers: 2022-0756NCI-2023-00783
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary; Lung

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Procedure: Lateral Decubitus Strategy (LADS)

Interventions

Lateral Decubitus Strategy (LADS) PROCEDURE

Given

Group 2

Ventilatory Strategy To Prevent Atelectasis PROCEDURE

Given

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 45 days prior to bronchoscopy.
• Voluntary informed consent to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Boster JM, Goertzen M, Sarkiss M, Armas Villalba AJ, Bhandari BS, Song J, Jimenez CA, Sabath BF, Lin J, Grosu HB, Ost DE, Eapen GA, Chintalapani G, Casal RF. Superiority of Lateral Decubitus Strategy in Preventing Atelectasis From Obscuring Targets During Robotic Bronchoscopy: Lateral Decubitus Strategy vs Ventilatory Strategy to Prevent Atelectasis Trial. Chest. 2026 Jan 8:S0012-3692(25)05835-0. doi: 10.1016/j.chest.2025.11.044. Online ahead of print.

  PMID: 41513124 DERIVED

Related Links

• M D Anderson Cancer Center

Study Officials

• Roberto Casal, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: February 10, 2023
• Primary Completion (Estimated): September 14, 2032
• Study Completion (Estimated): September 14, 2032
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)