Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome

Last updated: November 13, 2024
Sponsor: Children's Hospital Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

N/A

Clinical Study ID

NCT06690801
CHLA-24-00209
R01HL173488
  • Ages < 21
  • All Genders

Study Summary

The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction [AVDSf]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS).

The study aims are:

  1. To validate AVDSf for risk stratification of mortality in pediatric ARDS

  2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf

  3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association

This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >37 weeks corrected gestational age to 21 years, including adults lacking thecapacity to consent.

  • Within 72 hours of the start of invasive mechanical ventilation and meet thecriteria for pediatric ARDS (new infiltrate on chest imaging and a known ARDS riskfactor within 7 days of the onset of hypoxemia) and either meet criteria formoderate or severe pediatric ARDS between 4-72 hours of IMV (OI ≥ 8 or OSI ≥ 7.5) ORhave an OI ≥ 20 or an OSI ≥ 14 x 15 minutes between 0-4 hours of IMV.

  • Subgroup of children eligible for longituduinal Blood Collection: Children withsevere PARDS (OI ≥ 16 or an OSI ≥ 12 between 4-72 hours of IMV) or those with an OI ≥ 20 or an OSI ≥ 14 for 15 minutes between 0-4 hours of IMV will be eligible forcollection of longitudinal plasma samples.

Exclusion

Exclusion Criteria:

  • Non-conventional invasive mechanical ventilation (i.e. High Frequency OscillatoryVentilation, Airway Pressure Release Ventilation) at the time of ICU admission

  • ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICUadmission

  • Significant lower airways obstruction (examination of ventilator and capnographywaveforms by site study or medical team)

  • Air leak >20% (endotracheal tube, tracheostomy tube, or thoracostomy tube)

  • Home Invasive Mechanical Ventilation

  • Cyanotic Congenital Heart Disease

  • Previous enrollment in the DiNO study

  • Do not resuscitate order at the time of pediatric ARDS diagnosis.

  • Blood gas not obtained prior to initiation of ECMO, iNO, or non-conventionalventilation.

Study Design

Total Participants: 1260
Study Start date:
October 03, 2024
Estimated Completion Date:
February 01, 2029

Connect with a study center

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Denver, Colorado 80204
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Michigan / CS Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Nebraska Medical Center / Children's Hospital and Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Texas Children's Hospital Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • American Family Children's Hospital / University of Wisconsin-Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Children's Hospital of Wisconsin / Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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