Clinical Decision Support Tool in PARDS Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChildren's Hospital Los Angeles
About this trial
Previous clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS).
This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses:
1. The CDS tool in will be implementable in nearly all participating sites 2. There will be \> 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs
Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children > 1 month of age and >44 weeks gestation and ≤ 18 years of age AND
Supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4 AND
Who are within 72 hours of initiation of invasive mechanical ventilation AND
Who are anticipated to require >72 hours mechanical ventilation.
Disqualifiers
Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, bronchiolitis, critical airway, Extra Corporeal Life Support (ECLS), intubation for Upper Airway Obstruction, Do Not Resuscitate orders, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)
Primary Attending physician refuses to enroll the patient
Trial design
Design model
Single group
Treatments tested in this trial
Ventilator protocol
Other interventionopen loop ventilator management by a computer based protocol
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Aim 1: Implementation Feasibility
The main outcome for Aim 1 is the ability to install the CDS tool in at least 7 of the 9 potential institutions and get data from each of the minimum of 140 patients anticipated to be enrolled. The survey data will be qualitatively assessed for themes related to barriers to implementation and consider this in future refinements of the CDS tool.
Time frame
through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.2
Aim 2: Protocol Adherence
Acceptance of recommendations (between 75-85%) will be the main outcome used to determine correctness of interpretation and acceptability of the CDS Tool.
Time frame
through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.Sponsors and contacts
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Source ClinicalTrials.gov