PulmonaryNCT05714033
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
A study testing Ventilatory Strategy To Prevent Atelectasis and Lateral Decubitus Strategy (LADS) in people with Pulmonary and Lung, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ventilatory Strategy To Prevent Atelectasis and Lateral Decubitus Strategy (LADS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.
Read the 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.
- 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.
- Being tested
- Ventilatory Strategy To Prevent Atelectasis, Lateral Decubitus Strategy (LADS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilatory Strategy To Prevent AtelectasisProcedure or surgery
Given
Lateral Decubitus Strategy (LADS)Procedure or surgery
Given
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ventilatory Strategy To Prevent Atelectasis |
| Group 2 | Experimental | Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy. Receives: Procedure: Lateral Decubitus Strategy (LADS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start10 Feb 2023
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulmonaryStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Casal, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714033
- Sponsor's protocol ID
- 2022-0756
- Other IDs
- NCI-2023-00783
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Apr;169(4):1124-1134. doi: 10.1016/j.chest.2025.11.044. Epub 2026 Jan 8.
PubMed 41513124
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
- ClinicalTrials.gov ID
- NCT05714033
- Acronym / sponsor ID
- 2022-0756
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Ventilatory Strategy To Prevent AtelectasisGroup 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy |
| Group 2 | Experimental | Procedure: Lateral Decubitus Strategy (LADS)Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilatory Strategy To Prevent AtelectasisGiven | Procedure or surgery | Group 1 |
| Lateral Decubitus Strategy (LADS)Given | Procedure or surgery | Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 41513124Boster 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 Apr;169(4):1124-1134. doi: 10.1016/j.chest.2025.11.044. Epub 2026 Jan 8.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Casal, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilatory Strategy To Prevent Atelectasis and Lateral Decubitus Strategy (LADS) in people with Pulmonary and Lung, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.