RECRUITING

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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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-02-10

Study Completion:2032-09-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05714033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Roberto Casal, MD

CONTACT

(832) 287-9479

rfcasal@mdanderson.org

Principal Investigator

Roberto Casal, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Roberto Casal, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10

Study Completion Date2032-09-14

Study Record Updates

Study Start Date2023-02-10

Study Completion Date2032-09-14

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary
Lung