Recruiting

Observational Study

Sponsor:

Children's Hospital Los Angeles

Code:

NCT04068012

Conditions

Ventilation Therapy; Complications

Ventilator-Induced Lung Injury

Ards

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Ventilator protocol

Study Details

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).

Conditions

Ventilation Therapy; Complications

Ventilator-Induced Lung Injury

Ards

Study ID

NCT04068012

Start date

Dec 1, 2020

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

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

Interventions

Ventilator protocol

open loop ventilator management by a computer based protocol

Primary outcome measure

  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Christopher J Newth, MD

3233612557cnewth@chla.usc.edu

Robinder G Khemani, MD

3233612376rkhemani@chla.usc.edu

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Penn State University

Recruiting

Hershey, Pennsylvania, United States, 17033

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53715

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-04-14.