Computerized Ventilator Management for Respiratory Diseases

(REDvent Trial)

Overseen By Robinder G Khemani, MD,MsCI

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Severe airway obstruction, ECLS, others

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

I am on a ventilator due to lung disease and need a high level of oxygen.

I started using a breathing machine less than 48 hours ago, or less than 72 hours ago if I was transferred.

Exclusion Criteria

Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy)

I cannot be weaned off support due to severe health issues.

Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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).

Varies per patient

Continuous monitoring

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.

Up to 28 days

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Post-extubation monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Real-time Effort Driven ventilator management (REDvent)

Trial Overview The study tests a new computer-based ventilator management called REDvent against usual care. It aims to maintain normal breathing effort in critically ill kids using real-time data and reduce the time spent on mechanical ventilation by adjusting support based on muscle strength and architecture assessments.

How Is the Trial Designed?

Group I: REDvent-weaning Experimental Treatment 5 Interventions

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 (whichever comes first). Patients who pass the initial SBT at the end of the acute phase will not undergo weaning phase randomization. Patients will be managed in a pressure support/CPAP mode of ventilation with assessments or changes to the level of pressure support every 4 hours, targeting maintaining effort of breathing (esophageal manometry) in a normal range. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.

Group II: REDvent-acute Experimental Treatment 5 Interventions

Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Patients will be managed with pressure control plus pressure support ventilation using a computerized decision support tool that will recommend changes to ventilator settings approximately every 4 hr (with or without a new blood gas). If the patient is spontaneously breathing, it will incorporate real-time measures of effort of breathing (esophageal manometry) to keep it in a target range.

Group III: Control-weaning Placebo Group 4 Interventions

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 (whichever comes first). Patients who pass the initial SBT at the end of the acute phase will not undergo weaning phase randomization. Ventilator management will be per usual care. An SBT will be conducted daily, and the weaning phase will continue until the patient passes the SBT.

Group IV: Control-acute Placebo Group 4 Interventions

Acute Phase: The acute phase is defined as the time from intubation until the patient meets weaning criteria, passes the initial oxygenation test (decrease PEEP to 5 cmH2O and FiO2 to 0.5, maintains SpO2 \> 90%), and undergoes a Spontaneous Breathing Trial (SBT). Ventilator management will be per usual care until the patient meets weaning criteria and passes the oxygenation test.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

An electronic algorithm was developed to monitor ventilator settings in real-time, alerting healthcare providers to potentially harmful settings, which was tested on 1,159 patients in intensive care units.

After implementing the alert system, the average exposure to potentially injurious ventilation settings significantly decreased from 40.6 hours to 26.9 hours, indicating improved safety in ventilator care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. Herasevich, V., Tsapenko, M., Kojicic, M., et al.[2010]

A new wireless cellular interface for the Pulmonetic Systems LTV 1200 ventilator allows real-time access to ventilator settings and performance data, which can enhance care for technology-dependent children on chronic ventilator support.

Pediatric pulmonologists overwhelmingly support the remote interface, indicating it could reduce hospital visits and improve comfort for caregivers and children by facilitating better communication and monitoring of patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine enabled remote critical care ventilator. Seifert, GJ., Hedin, DS., Dahlstrom, RJ., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7609612/

The REDvent Pilot Study - PMC Introduction. Mechanical ventilation of adults and children with acute respiratory failure necessitates balancing lung and diaphragm protective ventilation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03266016

Real-time Effort Driven VENTilator Management (REDvent) REDvent offers systematic recommendations to reduce controlled ventilation during the acute phase of MV, and uses real-time measures from esophageal manometry ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32976348/

Real-Time Effort Driven Ventilator Management: A Pilot Study Through a Phase I clinical trial, we sought to determine whether a computerized decision support-based protocol (real-time effort-driven ventilator management) ...

4. researchgate.net researchgate.net/publication/344390958_Real-Time_Effort_Driven_Ventilator_Management_A_Pilot_Study

Real-Time Effort Driven Ventilator Management: A Pilot Study Through a Phase I clinical trial, we sought to determine whether a computerized decision support-based protocol (real-time effort-driven ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714419306081

A Phase II randomized controlled trial for lung and ... A novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can balance lung and diaphragm protective ventilation to reduce time ...

6. withpower.com withpower.com/trial/phase-respiratory-tract-diseases-9-2017-401d2

Computerized Ventilator Management for Respiratory ... It aims to maintain normal breathing effort in critically ill kids using real-time data and reduce the time spent on mechanical ventilation by adjusting support ...