Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ARDS
  • Ventilation Therapy; Complications
  • Ventilator Induced Lung Injury
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 118 years
Gender
Both males and females

Description

The central hypothesis is that CDS will help standardize ventilator management consistent with evidence-based recommendations leading to shorter LMV by limiting VILI (Ventilator Induced Lung Injury), preventing VIDD (Ventilator Induced Diaphragm Dysfunction) and allowing earlier recognition that pat...

The central hypothesis is that CDS will help standardize ventilator management consistent with evidence-based recommendations leading to shorter LMV by limiting VILI (Ventilator Induced Lung Injury), preventing VIDD (Ventilator Induced Diaphragm Dysfunction) and allowing earlier recognition that patients are ready for liberation from the ventilator. However, key questions must be addressed prior to wide dissemination of this CDS tool: Specific Aim 1: To assess the feasibility of implementing a web-based, de-identified CDS tool for MV in pediatric ARDS in multiple PICUs. Hypothesis: this CDS tool will be implementable in all PICUs to function consistent with each hospital's specific Information Technology (IT) capabilities. Specific Aim 2: To assess the acceptability and compliance with recommendations from the CDS tool related to oxygenation, ventilation, weaning and extubation readiness testing in PARDS patients at each of the participating PICUs (anticipated 20 patients enrolled per site). Hypothesis: over time, adherence with recommendations in each of these domains will exceed 80% in all PICUs. Specific Aim 3: To implement methods for automated data capture within CDS to provide the right information, to the right person, using the right format, in the right channel and at the right time during workflow ("CDS Five Rights") framework, which can be adapted to the individual IT capabilities at each hospital. Hypothesis: Over 90% of necessary data can be pulled into the CDS in an automated fashion in sites which have access to electronic data capture of ventilator settings and blood gases. Patients will be managed on the eVentilator protocol (the CDS tool), through the acute, stable and weaning phases of mechanical ventilation, including Spontaneous Breathing tests (SBTs) and Extubation Readiness tests. Data will be qualitatively assessed for implementation barriers. Acceptance and rejection and mode stratification will be examined. Data needed for the CDS protocol will be available electronically or can be interfaced through the bedside monitor. Patients will be on the CDS protocol, as intent to treat, while patient is on invasive mechanical ventilation, capped at 28 days, limitation of care, or death, whichever comes first.

Tracking Information

NCT #
NCT04068012
Collaborators
Not Provided
Investigators
Not Provided