Clinical Decision Support Tool in PARDS Pilot Study

NCT04068012 | Recruiting

• 1 other identifier: CHLA-19-00085
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 8

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. 1.The CDS tool in will be implementable in nearly all participating sites
2. 2.There will be \> 80% compliance with CDS recommendations and
3. 3.The investigators can implement automatic data capture and entry in many of the ICUs

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Intervention

EXPERIMENTAL

Ventilator management using the proposed protocol in both acute and weaning phases

Other: Ventilator protocol

Interventions

Ventilator protocol OTHER

open loop ventilator management by a computer based protocol

Intervention

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (8)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Penn State University

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

NOT YET RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, Canada

RECRUITING

Ospedale Pediatrico Bambino Gesu

Roma, Italy

NOT YET RECRUITING

Related 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.

  PMID: 32976348 BACKGROUND

• 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.

  PMID: 31740425 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christopher J Newth, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Newth, MD

CONTACT

3233612557; cnewth@chla.usc.edu

Robinder G Khemani, MD

CONTACT

3233612376; rkhemani@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: December 1, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CA (1); IT (1); US (6)