Computerized Ventilator Management for Respiratory Diseases
(REDvent Trial)
Trial Summary
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 data supports the effectiveness of the treatment Real-time Effort Driven ventilator management (REDvent)?
Research shows that computer-assisted management of ventilators can improve patient outcomes. For example, in one study, neonates with respiratory failure had better blood gas values when managed with computer guidance compared to those without. This suggests that computerized systems like REDvent could be effective in managing respiratory diseases.12345
Is computerized ventilator management generally safe for humans?
Research shows that computerized ventilator systems have been used successfully in patients, with features designed to improve safety by monitoring and adjusting ventilator settings in real-time to prevent lung injury. Additionally, remote monitoring technology has been positively received by medical professionals, suggesting it is considered safe and beneficial for patient care.678910
How is the REDvent treatment different from other treatments for respiratory diseases?
REDvent is unique because it uses a computerized system to manage ventilator settings in real-time, adjusting based on the patient's effort and needs. This approach aims to optimize ventilation more effectively than traditional methods, which often rely on manual adjustments by healthcare providers.12111213
What is the purpose of this trial?
This study is a Phase II controlled clinical trial that will obtain comprehensive, serial assessments of respiratory muscle strength and architecture to understand the evolution of ventilator-induced respiratory muscle weakness in critically ill children, and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic recommendations to reduce controlled ventilation during the acute phase of MV, and uses real-time measures from esophageal manometry to adjust supported ventilator pressures such that patient effort of breathing remains in a normal range during the ventilator weaning phase. This phase II clinical trial is expected to enroll 276 children with pulmonary parenchymal disease, anticipated to be ventilated \> 48 hrs. Patients will be randomized to REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning (time from first SBT until successful passage of an SBT or extubation (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this study will provide important information on the pathogenesis and timing of respiratory muscle weakness during MV in children and whether this weakness can be mitigated by promoting more normal patient effort during MV via the use of REDvent. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day Ventilator Free Days.
Research Team
Robinder G Khemani, MD, MsCI
Principal Investigator
Children's Hospital Los Angeles
Eligibility Criteria
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
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
Treatment Details
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