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

248 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 11 12 13}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computer-based respiratory care algorithms. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of computer-assisted management of respiratory failure in neonates. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Implementation of Lung-Protective Ventilation in Patients With Acute Respiratory Failure. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Stochastic integrated model-based protocol for volume-controlled ventilation setting. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Response of Home-Use Adaptive Pressure Modes to Simulated Transient Hypoventilation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Limiting ventilator-induced lung injury through individual electronic medical record surveillance. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Ventilator-Associated Events: Epidemiology, Risk Factors, and Prevention. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Microprocessor-controlled ventilator monitor with pre-evaluation of preset variables and graphic simulation: a preliminary clinical impression. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Telemedicine enabled remote critical care ventilator. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The usability of ventilators: a comparative evaluation of use safety and user experience. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Computational tool for modeling and simulation of mechanically ventilated patients. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Current status of mechanical ventilation decision support systems: a review. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Mechanical ventilation: past lessons and the near future. [2021]