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A computer-driven ventilator liberation protocol in pediatric patients: a single-center pilot randomized controlled
Song Chen1, Changxue Xiao1, Xue Lu1
1Department of Critical Care Medicine, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism and Inflammatory Diseases, Chongqing, China.
Insights
This pilot study found a computer-driven protocol for liberating pediatric patients from invasive mechanical ventilation (IMV) feasible. Further trials are needed to confirm its utility in improving patient outcomes.
Area of Science:
- Pediatric Intensive Care Medicine
- Mechanical Ventilation
- Clinical Trial Feasibility
Background:
- Timely liberation from invasive mechanical ventilation (IMV) is crucial for pediatric patients.
- Assessing the feasibility of novel protocols is essential before larger clinical trials.
- Computer-driven protocols may offer a standardized approach to ventilator weaning.
Purpose of the Study:
- To determine the feasibility of a study protocol for a larger prospective trial.
- To examine the utility of a computer-driven liberation protocol in pediatric patients.
Main Methods:
- Single-center pilot randomized controlled trial in a pediatric intensive care unit (PICU).
- 40 pediatric patients (28 days to 18 years) undergoing IMV for >24 hours were randomized (1:1).
- Test group used a computerized algorithm for liberation; control group received standard care.
Main Results:
- No significant differences in duration of IMV between the test (95.3h) and control (113.3h) groups (p=0.62).
- Pediatric intensive care unit (PICU) length of stay was similar: 6.9 days (test) vs. 7.0 days (control) (p=0.74).
- Hospital length of stay was also similar: 22.9 days (test) vs. 26.9 days (control) (p=0.31).
Conclusions:
- The pilot study suggests that conducting a larger prospective trial of a computer-driven ventilator liberation protocol is feasible.
- A larger trial is necessary to further explore the utility of this computer-driven approach.
- The current pilot did not demonstrate a significant difference in key outcomes but supports feasibility for future research.
Objective:
Timely liberation from invasive mechanical ventilation (IMV) is important. We aimed to determine the feasibility of our study protocol for the conduction of a larger prospective trial to examine the utility of a computer-driven liberation protocol in pediatric patients.
Design:
Single-center pilot randomized controlled trial.
Setting:
Single, tertiary care, 52-bed, academic pediatric intensive care unit (PICU).
Patients:
Patients aged from 28 days to 18 years undergoing IMV for more than 24 h.
Interventions:
Patients were randomly assigned to test and control groups in a ratio of 1:1. The test group underwent ventilator liberation driven by a computerized algorithm combining protocolized screening, air leak testing, and spontaneous breathing testing. The control group underwent ventilator liberation driven by the attending physician according to standard care.
Measurements And Main Results:
A total of 40 patients (20 in each group) were randomized. Baseline characteristics of the two groups were similar. Durations of IMV were 95.3 h (95%CI, 9.07-181.53) in the test group and 113.3 h (95%CI, 85.90-140.70) in the control group and were similar (p = 0.62). PICU length of stay [6.9 days [95%CI, 5.00-8.86] vs. 7.0 days [95%CI, 5.58-8.40]; p = 0.74] and hospital length of stay [22.9 days [95%CI, 11.48-34.24] vs. 26.9 days [95%CI, 17.86-35.94]; p = 0.31] were similar between the test and control groups, respectively.
Conclusions:
Our pilot study suggests that the conduction of a larger prospective trial of a computer-driven ventilator liberation protocol is feasible in our PICU. And a larger trial is needed to further explore the utility of a computer-driven ventilator liberation protocol.
Clinical Trial Registration:
https://www.chictr.org.cn/showproj.html?proj=168024, Chinese Clinical Trial Registry ChiCTR2200060033.
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