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Clinical Decision Support Tool in PARDS Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04068012
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : January 7, 2020
Information provided by (Responsible Party):
Children's Hospital Los Angeles

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Ventilation Therapy; Complications Ventilator-Induced Lung Injury Ards Other: Ventilator protocol Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: Intervention
Ventilator management using the proposed protocol in both acute and weaning phases
Other: Ventilator protocol
open loop ventilator management by a computer based protocol

Primary Outcome Measures :
  1. Aim 1: Implementation Feasibility [ Time Frame: through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first. ]
    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.

  2. Aim 2: Protocol Adherence [ Time Frame: through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first. ]
    Acceptance of recommendations (between 75-85%) will be the main outcome used to determine correctness of interpretation and acceptability of the CDS Tool.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Children > 1 month of age and >44 weeks gestation and ≤ 18 years of age AND
  2. 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
  3. Who are within 72 hours of initiation of invasive mechanical ventilation AND
  4. Who are anticipated to require >72 hours mechanical ventilation.

Exclusion Criteria:

  1. 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
  2. Conditions precluding the use of permissive hypercapnia or hypoxemia (i.e. intracranial hypertension, severe pulmonary hypertension)
  3. Primary Attending physician refuses to enroll the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04068012

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Contact: Christopher Newth, MD 3233612557

Sponsors and Collaborators
Children's Hospital Los Angeles
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Responsible Party: Children's Hospital Los Angeles Identifier: NCT04068012    
Other Study ID Numbers: CHLA-19-00085
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries