Clinical Decision Support Tool in PARDS Pilot Study

Ards Clinical Trial

Official title:

A Computerized Decision Support Tool for Ventilator Management in Pediatric Acute Respiratory Distress Syndrome Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068012
• Other study ID #: CHLA-19-00085
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Children's Hospital Los Angeles
• Contact: Christopher J Newth, MD
• Phone: 3233612557
• Email: cnewth[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ards
• Lung Injury
• Ventilation Therapy; Complications
• Ventilator-Induced Lung Injury

Intervention

Other:
• Ventilator protocol
open loop ventilator management by a computer based protocol

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec
Italy	Ospedale Pediatrico Bambino Gesu	Roma
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Penn State University	Hershey	Pennsylvania
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

References & Publications (2)

Hotz JC, Bornstein D, Kohler K, Smith E, Suresh A, Klein M, Bhalla A, Newth CJ, Khemani RG. Real-Time Effort Driven Ventilator Management: A Pilot Study. Pediatr Crit Care Med. 2020 Nov;21(11):933-940. doi: 10.1097/PCC.0000000000002556. — View Citation

Khemani RG, Hotz JC, Klein MJ, Kwok J, Park C, Lane C, Smith E, Kohler K, Suresh A, Bornstein D, Elkunovich M, Ross PA, Deakers T, Beltramo F, Nelson L, Shah S, Bhalla A, Curley MAQ, Newth CJL. A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management). Contemp Clin Trials. 2020 Jan;88:105893. doi: 10.1016/j.cct.2019.105893. Epub 2019 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.
Primary	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.	through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.