Low-Intensity Mechanical Ventilation for Pulmonary Complications
(VIOLET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether Low Intensity Mechanical Ventilation, a gentle method of assisting breathing during robot-assisted surgeries, can reduce the risk of lung issues afterward. It compares this new approach with standard care during surgery. The trial targets adults undergoing planned abdominal or pelvic surgeries lasting at least two hours. As an unphased trial, it allows patients to contribute to innovative research that could enhance surgical outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this low-intensity mechanical ventilation is safe for reducing pulmonary complications?
Research has shown that protective lung ventilation can lower the risk of lung problems after surgery. Patients who received this type of ventilation experienced fewer lung issues compared to those who received standard ventilation. This suggests that a gentler form of mechanical ventilation, integral to this protective approach, may be safer for surgical patients.
However, while protective ventilation appears promising for reducing lung problems, evidence regarding other issues, such as heart problems during surgery, remains unclear. One study found that patients whose ventilators worked harder experienced more serious heart problems, but this study did not focus on the gentler ventilation method.
Overall, gentler mechanical ventilation seems well-tolerated and could offer safety benefits, particularly for lung health during and after surgery.12345Why are researchers excited about this trial?
Researchers are excited about low-intensity mechanical ventilation for pulmonary complications because it aims to minimize lung injury during surgeries, a common risk with traditional mechanical ventilation methods. Unlike standard care, which often involves higher pressures and volumes, this approach uses gentler settings to protect the lungs. By adjusting ventilator settings to be less intense, this method could reduce the likelihood of complications like atelectasis, thereby improving patient outcomes and recovery times. This innovative approach could redefine how mechanical ventilation is applied, offering a safer alternative to current practices.
What evidence suggests that low-intensity mechanical ventilation is effective for reducing pulmonary complications?
Research shows that gentle breathing support during surgery can reduce lung problems afterward. In this trial, participants in the intervention arm will receive a bundle of protective low-intensity mechanical ventilation strategies. One study found that patients who received this protective breathing method were 1.17 times less likely to have lung issues compared to those with standard breathing support. They experienced fewer breathing problems and recovered better. The idea is that softer settings help protect the lungs from stress during surgery. This method is being tested in this trial to see if it can prevent problems like atelectasis, where the lungs don't fully expand. Overall, early results are promising for reducing lung problems after surgery with gentle breathing support.678910
Are You a Good Fit for This Trial?
This trial is for adults scheduled for elective intra-abdominal or pelvic robot-assisted surgery lasting at least 2 hours under general anesthesia with planned extubation afterwards. It excludes pregnant individuals, those already intubated or with a tracheostomy, and anyone who can't use certain monitoring devices due to other medical devices or recent surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intraoperative
Protective low-intensity mechanical ventilation strategies are applied during robot-assisted surgery
Postoperative Monitoring
Participants are monitored for postoperative pulmonary complications and other outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Mechanical Ventilation
Trial Overview
The study tests if low-intensity mechanical ventilation during robotic surgery can reduce lung collapse (atelectasis) and breathing problems after surgery compared to standard care. The practicality of using this protective ventilation method will also be evaluated.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings.
A guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Citations
Effect of protective lung ventilation on pulmonary ...
Patients receiving protective lung ventilation were 1.17 times less likely to develop pulmonary complications after surgery than those receiving conventional ...
Short- and long-term outcomes of pulmonary emphysema ...
The aim of this study was to assess the short- and long-term outcomes of ICU patients with pulmonary emphysema requiring mechanical ventilation for acute ...
Epidemiology, Mechanical Power, and 3-Year Outcomes in ...
Patients sustaining the diagnosis of ARDS had a hospital mortality of 26.5% for mild, 31.8% for moderate, and 60.0% for severe ARDS and a 3-year ...
Comparison of clinical outcomes in critical patients ...
PAV mode effectively reduced respiratory work, relieved respiratory muscle fatigue, and improved man–machine coordination and the quality of ...
Mechanical Ventilation and Clinical Outcomes in Patients with ...
In-hospital mortality rates for patients without MV, with exclusively non-invasive MV, and with invasive MV were 4.0%, 8.8%, and 39.5%, respectively (P<0.001).
Impact of ventilation strategies on pulmonary and ...
Postoperative pulmonary complications did not differ between HP and LP groups; the incidence of intraoperative cardiovascular complications was higher in HP ...
The Association Between Mechanical Power Within the First ...
Results: High MP within the first 24 hours was associated with increased ICU mortality (OR, 1.58; 95% CI, 1.44-1.72), but no definitive safe MP ...
The Association Between Mechanical Power Within ...
A recent study determined that an MP of > 17 J/min during the second 24 hours of IMV was associated with increased mortality in patients with ARDS, suggesting ...
Effect of protective lung ventilation on pulmonary ...
Patients receiving protective lung ventilation were 1.17 times less likely to develop pulmonary complications after surgery than those receiving conventional ...
Epidemiology, Patterns of Care, and Mortality for Patients ...
A total of 2377 patients developed ARDS in the first 48 hours of acute hypoxemic respiratory failure and received invasive mechanical ...
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