Computerized Ventilator Management for Respiratory Diseases
(REDvent Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new computer-based system, called REDvent, designed to assist children with serious lung diseases who require mechanical ventilators. The goal is to determine if REDvent can strengthen their breathing muscles and reduce ventilator dependency time. The trial consists of two parts: one group will use REDvent while on the ventilator, and the other group will receive standard care. Children who have been on a ventilator for less than 48 hours due to conditions like pneumonia or severe respiratory distress may qualify.
As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance care for children on ventilators.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this computerized ventilator management approach is safe for children with respiratory diseases?
Research has shown that the Real-time Effort Driven ventilator management (REDvent) system underwent safety testing in earlier studies. In these studies, patients using REDvent experienced more days without needing a ventilator and spent less time on mechanical ventilation, suggesting that REDvent is generally well-tolerated.
While specific reports of negative effects are absent from the sources provided, the controlled clinical trial ensures close monitoring of REDvent's safety. This is crucial, as the trial involves critically ill children. The trial phase and previous study results indicate that REDvent is safe enough for continued testing. However, participants should be informed and discuss any concerns with their healthcare providers.12345Why are researchers excited about this trial?
Researchers are excited about the REDvent system for respiratory diseases because it offers a cutting-edge approach to ventilator management. Unlike standard care, which often relies on fixed settings or periodic adjustments, REDvent uses real-time, effort-driven management. This system incorporates esophageal manometry to measure a patient's breathing effort, allowing for more personalized and responsive ventilation adjustments. By continuously optimizing ventilator settings, REDvent aims to improve patient outcomes and potentially shorten the time patients need mechanical ventilation.
What evidence suggests that the REDvent approach is effective for managing respiratory muscle strength in critically ill children?
Research shows that the Real-time Effort Driven ventilator management (REDvent) method, which participants in this trial may receive, can improve mechanical ventilation management. Early results suggest that REDvent shortens the time patients need to be on a ventilator by using a computer system to adjust settings instantly. This system measures pressure in the esophagus to ensure the patient's breathing effort remains normal. Studies indicate that this method protects both the lungs and the diaphragm, helping to maintain muscle strength. REDvent could lead to shorter ventilation times and better outcomes for patients with breathing problems.12346
Who Is on the Research Team?
Robinder G Khemani, MD, MsCI
Principal Investigator
Children's Hospital Los Angeles
Are You a Good Fit for This Trial?
This trial is for children aged 1 month to 18 years on mechanical ventilation due to lung diseases like pneumonia, with specific oxygen needs. They must be within the first 48-72 hours of invasive ventilation. Kids can't join if they have conditions that prevent esophageal catheter use, need chest immobilization, or have abdominal wall defects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acute Phase
The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test, and undergoes a Spontaneous Breathing Trial (SBT).
Weaning Phase
The weaning phase is defined as the time from the first Spontaneous Breathing Trial (SBT) until the patient successfully passes an SBT or is extubated.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Real-time Effort Driven ventilator management (REDvent)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Los Angeles
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Children's Hospital of Philadelphia
Collaborator