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Computerized Ventilator Management for Respiratory Diseases (REDvent Trial)

N/A
Recruiting
Led By Robinder G Khemani, MD, MsCI
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Supported on mechanical ventilation with pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥
Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 and 60 days
Awards & highlights

REDvent Trial Summary

This trial is testing whether a new computer-based approach can reduce ventilator-induced respiratory muscle weakness in critically ill children. The primary clinical outcome is length of weaning (time from first Spontaneous Breathing Trial (SBT) until successful passage of an SBT or extubation (whichever comes first)).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from esophageal catheters or RIP bands, risks associated with ultrasound procedures, and possible issues arising from adjustments in ventilator support.

REDvent Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a ventilator due to lung disease and need a high level of oxygen.
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I started using a breathing machine less than 48 hours ago, or less than 72 hours ago if I was transferred.
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I am between 1 month and 18 years old.

REDvent Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 and 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Duration of Weaning
Secondary outcome measures
Median Change in diaphragm thickness on Exhalation (Dte) from baseline
Median Maximal Inspiratory Airway Pressure During Airway Occlusion (aPiMax)
Median Maximal Inspiratory Esophageal Pressure During Airway Occlusion (ePiMax)
+3 more

REDvent Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: REDvent-weaningExperimental Treatment5 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-acuteExperimental Treatment5 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-weaningPlacebo Group4 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-acutePlacebo Group4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophageal Manometry
2013
N/A
~40
Maximal Inspiratory Pressure
2015
N/A
~20

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
230 Previous Clinical Trials
5,076,166 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,161 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
706 Previous Clinical Trials
8,571,164 Total Patients Enrolled

Media Library

Real-time Effort Driven ventilator management (REDvent) Clinical Trial Eligibility Overview. Trial Name: NCT03266016 — N/A
Ventilation Therapy Complications Research Study Groups: REDvent-weaning, Control-weaning, Control-acute, REDvent-acute
Ventilation Therapy Complications Clinical Trial 2023: Real-time Effort Driven ventilator management (REDvent) Highlights & Side Effects. Trial Name: NCT03266016 — N/A
Real-time Effort Driven ventilator management (REDvent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266016 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the screening requirements for this clinical trial?

"This study is looking for 276 young patients aged between 1 month and 18 years that suffer from respiratory diseases. Importantly, these children must be within 48 hours of starting invasive mechanical ventilation (though 72 hours is allowed for those transferred from another institution)."

Answered by AI

Does this test only include those under 45, or are older patients eligible as well?

"The age restriction for this clinical study is 30 days to 18 years old."

Answered by AI
Recent research and studies
~7 spots leftby May 2024