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Procedure
Ventilatory Strategy for Atelectasis
N/A
Waitlist Available
Led By Roberto F Casal
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial compares VESPA to standard mechanical ventilation for preventing atelectasis during bronchoscopy under general anesthesia.
Who is the study for?
This trial is for adults who need a bronchoscopy with ultrasound for lung issues, and have had a chest CT scan in the last 4 weeks. It's not for those with diaphragmatic paralysis, excessive air retention, large lung bullae, ascites, history of spontaneous pneumothorax, pregnant women or if there are significant changes or masses in certain areas of their lungs.Check my eligibility
What is being tested?
The VESPA trial is testing whether a new ventilatory strategy can prevent atelectasis (lung collapse) better than standard mechanical ventilation during bronchoscopy under general anesthesia in patients with lung disease.See study design
What are the potential side effects?
Potential side effects may include discomfort from the different ventilation method and risks typically associated with general anesthesia such as nausea, sore throat, dizziness and rarely more serious complications like respiratory problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence or absence of atelectasis for each patient
Presence or absence of atelectasis within each of the 6 bronchial segments
Presence or absence of new atelectasis for each segment
Secondary outcome measures
Bronchoscopy-induced complications
Ventilatory strategy to prevent atelectasis (VESPA)-induced complications
Side effects data
From 2020 Phase 2 trial • 28 Patients • NCT022301895%
Pregnancy identified during study enrollment
5%
Increased systolic blood pressure post-bronchoscopy
5%
Respiratory infection post-bronchoscopy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allergic Asthmatics(AA)
Allergic Non-Asthmatics(ANA)
Non-Allergic Non-Asthmatics(NANA)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (VESPA)Experimental Treatment2 Interventions
Patients receive anesthesia using a longer breathing tube called an endotracheal tube and then undergo standard of care bronchoscopy.
Group II: Group I (conventional mechanical ventilation)Active Control2 Interventions
Patients receive anesthesia using a standard short breathing tube called LMA and then undergo standard of care bronchoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anesthesia Procedure
2020
N/A
~80
Bronchoscopy
2002
Completed Phase 2
~2300
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,701 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,073 Total Patients Enrolled
Roberto F CasalPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My latest CT scan shows large lung masses or changes in specific areas of my lung.I had a chest CT scan within the last 4 weeks.I am an adult scheduled for a lung procedure using a special ultrasound.I have had a collapsed lung without injury.I have fluid buildup in my abdomen.I have been diagnosed with diaphragmatic paralysis.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (conventional mechanical ventilation)
- Group 2: Group II (VESPA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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