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Real-time Effort Driven VENTilator Management
NA trial testing Computerized Ventilator Protocol in Ventilation Therapy; Complications in 248 participants. Completed in 20 June 2024.
| Lead sponsor | Children's Hospital Los Angeles |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 248 |
| Start date | 21 October 2017 |
| Primary completion | 1 April 2024 |
| Estimated completion | 20 June 2024 |
| Sites | 1 location across United States |
Children's Hospital Los Angeles
Adults 30 Days to 18, any sex, with Ventilation Therapy; Complications or Diaphragm Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from first attempted SBT until SBT passage or extubation \[whichever comes first\]
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 0.09 | 0.08 – 2.03 |
| Acute: Control | 1.04 | 0.08 – 2.17 |
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 2.03 | 1.09 – 3.58 |
| Acute: Control | 2.10 | 1.08 – 4.05 |
Days alive and not on mechanical ventilation
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 21.9 | 14.0 – 24.5 |
| Acute: Control | 21.3 | 14.2 – 23.9 |
re-intubation
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 8 | |
| Acute: Control | 8 |
Death
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 21 | |
| Acute: Control | 18 |
Measured during standardized airway occlusion maneuvers
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 51.3 | 36.7 – 65 |
| Acute: Control | 44.0 | 34 – 60 |
Measured during standardized airway occlusion maneuvers
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | 41.09 | 27.5 – 52.17 |
| Acute: Control | 35.5 | 26.1 – 49.0 |
From daily ultrasound measurement
| Group | Value | 95% CI |
|---|---|---|
| Acute: REDvent | -2 | -25 – 14 |
| Acute: Control | -1 | -18 – 17 |
Time frame: 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acute: REDvent | Acute: Control | Weaning: REDvent | Weaning: Control |
|---|---|---|---|---|---|
| Air leak | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Progressive multi-organ failure | General disorders | — | — | — | — |
| Cardiac Arrest/ECMO | Cardiac disorders | — | — | — | — |
| Sustained hypoxemia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Intracranial event/hemorrhage | General disorders | — | — | — | — |
| Unplanned Extubation | Injury, poisoning and procedural complications | — | — | — | — |
| Arrythmia | Cardiac disorders | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Diffuse alveolar hemorrhage | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Progression of underlying neurologic disease | General disorders | — | — | — | — |
| Refractory shock | General disorders | — | — | — | — |
| Refractory brain tumor and hypoxemia | General disorders | — | — | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Acute: REDvent | Acute: Control | Weaning: REDvent | Weaning: Control |
|---|---|---|---|---|---|
| Sustained hypoxemia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Esphageal catheter in trachea-bronchial tree | Injury, poisoning and procedural complications | — | — | — | — |
| Failure of weaning phase | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Esophageal catheter complication | Injury, poisoning and procedural complications | — | — | — | — |
| Unplanned Extubation | Injury, poisoning and procedural complications | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Air leak | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Re-intubation | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Arrythmia | Cardiac disorders | — | — | — | — |
| Supra ventricular tachycardia | Cardiac disorders | — | — | — | — |
Most-reported serious reactions: Air leak, Progressive multi-organ failure, Cardiac Arrest/ECMO, Sustained hypoxemia, Intracranial event/hemorrhage, Unplanned Extubation, Arrythmia, Bradycardia.
Data from ClinicalTrials.gov NCT03266016 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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