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Published on: January 17, 2011
Randomized Trial of Lung and Diaphragm Protective Ventilation in Children
Robinder G Khemani1,2, Anoopindar Bhalla1,2, Justin C Hotz1
1Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles, Los Angeles.
Insights
A computerized decision support tool (REDvent) improved lung and diaphragm protective ventilation in children, significantly shortening the weaning duration. Further phase III trials are recommended for mechanically ventilated patients.
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Medical Informatics
Background:
- Mechanical ventilation strategies balancing lung and diaphragm protection require further clinical validation.
- Limited data exists on the efficacy of computerized decision support tools in pediatric mechanical ventilation.
Purpose of the Study:
- To evaluate a computerized decision support (CDS) tool, REDvent, combined with esophageal manometry for lung and diaphragm protective ventilation in children with ARDS.
- To compare the length of weaning in children receiving the REDvent intervention versus usual care.
Main Methods:
- A single-center, phase II randomized controlled trial involving 248 children with acute respiratory distress syndrome.
- Random assignment occurred during the acute and weaning phases of ventilation.
- The intervention group used the REDvent CDS tool and esophageal manometry; the control group received usual care. A daily spontaneous breathing trial (SBT) was conducted in both groups.
Main Results:
- During the acute phase, the REDvent group showed reduced peak inspiratory pressure (-3 cmH2O) and positive end-expiratory pressure (-2 cmH2O) compared to usual care.
- 55% of REDvent patients passed their SBT or were extubated on the first attempt, versus 39% in the usual care group.
- The REDvent intervention was associated with a 1.67 odds of shorter weaning duration (P=0.045), with a median time to SBT passage of 3.83 days vs. 4.75 days.
Conclusions:
- A lung and diaphragm protective ventilation strategy utilizing the REDvent CDS tool in the acute phase of ventilation shortened weaning duration in children.
- Clinical outcomes were similar between groups when random assignment occurred during the weaning phase.
- Further phase III trials are warranted to confirm these findings in mechanically ventilated patients.
Background:
Mechanical ventilation strategies that balance lung and diaphragm protection have not been extensively tested in clinical trials.
Methods:
We conducted a single-center, phase II randomized controlled trial in children with acute respiratory distress syndrome with two time points of random assignment: the acute and weaning phases of ventilation. Patients in the intervention group were managed with a computerized decision support (CDS) tool, named REDvent, and esophageal manometry to deliver lung and diaphragm protective ventilation. The control group received usual care. A daily standardized spontaneous breathing trial (SBT) was performed in both groups. The primary outcome was the length of weaning.
Results:
From October 2017 through March 2024, 248 children were randomly assigned to the acute phase. When participants were triggering the ventilator, the adjusted mean difference (REDvent-acute - usual care-acute) for peak inspiratory pressure was -3 cmH2O (95% CI, -5 to -2), positive end-expiratory pressure was -2 cmH2O (95% CI, -2 to -1), and the esophageal pressure swing was -1.8 cmH2O (95% CI, -3.2 to -0.3). For the primary outcome, 55% of REDvent-acute patients passed their SBT or were extubated on the day of the first SBT, compared with 39% in the usual care-acute group. After adjusting for age, immunosuppression, and oxygenation index value, the REDvent-acute intervention resulted in a 1.67 (95% CI, 1.01 to 2.77; P=0.045) odds of a shorter length of weaning than usual care. The median time from intubation to SBT passage was 3.83 days in the intervention group versus 4.75 days in the usual care group. The length of ventilation among survivors was 5.0 days in the intervention group versus 5.6 days in the usual care group. When comparing weaning phase random assignment, clinical outcomes were similar between groups. There were no differences in adverse events between the groups.
Conclusions:
A lung and diaphragm protective ventilation strategy using a CDS tool during the acute phase of ventilation resulted in a shorter length of weaning than usual care. Phase III trials in mechanically ventilated patients are warranted. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT03266016.).
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