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Individualized vs Standard Ventilation for Surgery
N/A
Waitlist Available
Led By William G Tharp, MD PhD
Research Sponsored by University of Vermont Medical 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 tee studies will be performed immediately after intubation, while in steep trendelenburg position, and just before desufflation of the abdomen.
Awards & highlights
Study Summary
This trial looks at how different ventilator settings during surgery affect the relationship between lung and heart pressures.
Who is the study for?
This trial is for adults over 18 who are having robotic-assisted laparoscopic surgery in a specific position at the University of Vermont Medical Center. They must be able to give consent and speak English. Smokers, those with significant past smoking history, lung diseases like asthma or COPD, heart problems, esophageal issues, or other conditions that could affect participation are excluded.Check my eligibility
What is being tested?
The study tests if different ventilator settings during surgery can influence how pressures in the lungs affect heart function. Patients will either receive standard ventilation or individualized adjustments based on pressure measurements taken every 30 minutes with a balloon catheter. Heart and lung function will be monitored using ultrasound before and after surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound probe insertion into the esophagus and stomach as well as risks associated with placing a small balloon catheter to measure chest pressures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tee studies will be performed immediately after intubation, while in steep trendelenburg position, and just before desufflation of the abdomen.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tee studies will be performed immediately after intubation, while in steep trendelenburg position, and just before desufflation of the abdomen.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine whether intraoperative transpulmonary pressure (TPP)-guided ventilation alters right heart function.
Secondary outcome measures
To determine the effect of obesity and surgical conditions on right heart function.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized lung protective ventilator settingsExperimental Treatment1 Intervention
Lung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry.
Group II: Standard lung protective ventilator settingsActive Control1 Intervention
Ventilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure.
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Who is running the clinical trial?
University of Vermont Medical CenterLead Sponsor
41 Previous Clinical Trials
25,775 Total Patients Enrolled
1 Trials studying Obesity
99 Patients Enrolled for Obesity
William G Tharp, MD PhDPrincipal InvestigatorUniversity of Vermont Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having robotic surgery in a specific position at the University of Vermont Medical Center.I need surgery urgently.I am unable to sign the consent form by myself.I am 18 years old or older.I have had issues with my esophagus, like narrowings, enlarged veins, or surgeries.My heart doesn't pump blood as well as it should.I cannot speak English.I have a lung condition like asthma or COPD.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Standard lung protective ventilator settings
- Group 2: Individualized lung protective ventilator settings
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this research endeavor for participants?
"This particular clinical trial, initially posted on January 30th 2023 and last updated on the 23rd of that same month, is not currently open for recruitment. Nevertheless, 1291 other studies are looking to admit patients at this time."
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