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Ventilation Strategies for Preventing Lung Collapse During Robotic Surgery
N/A
Recruiting
Led By Roberto Casal, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial compares two techniques to see which is better at preventing collapsed lung during a robotic surgery.
Who is the study for?
Adults undergoing diagnostic robotic bronchoscopy for suspicious lung nodules up to 3 cm, located in specific bronchial segments. Participants must have had a recent chest CT and over half the lesion's volume below a certain point on their spine. Excluded are those with history of pneumothorax, pregnancy, ascites, large lung bullae, diaphragmatic paralysis, severe air-trapping or mediastinal adenopathy requiring prior sampling.Check my eligibility
What is being tested?
The trial is testing two methods to prevent atelectasis (lung collapse) during robotic bronchoscopy: VESPA (a ventilatory strategy) and LADS (lying on one side). Patients will be randomly assigned to either method to see which is more effective.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying in one position during the procedure and risks typically associated with general anesthesia such as nausea, sore throat or muscle aches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung nodules are no larger than 3 cm and are in specific areas of my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.
Group II: Group 1Experimental Treatment1 Intervention
Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,981 Previous Clinical Trials
1,789,771 Total Patients Enrolled
Roberto Casal, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
171 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diaphragmatic paralysis.I have had lung issues or masses larger than 3 cm on my latest CT scan.I am an adult scheduled for a lung nodule check under anesthesia.My lung nodules are no larger than 3 cm and are in specific areas of my lungs.I have had a collapsed lung without injury.I have fluid buildup in my abdomen.People who need extra protection and care.You have lung bullae (air-filled spaces) larger than 5 cm.You had a chest CT scan less than 4 weeks before the bronchoscopy.You are a smoker or used to smoke and have a condition that traps air in your lungs.I need a lymph node biopsy for suspected cancer before a lung procedure.More than half of the lesion should be below a certain line drawn at the front of the spine bone.My cancer has spread outside the specific lung areas.I am currently suffering from COVID pneumonia.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation still ongoing?
"Reportedly, according to the clinicaltrials.gov page, this trial is no longer recruiting patients. Initially posted on July 30th 2023 and last updated in January 26th 2023, there are 15 other trials that participants can contribute to instead."
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