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

Description

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.

Conditions

Acute Respiratory Distress Syndrome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Respiratory Distress Syndrome
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Denver

Children's Hospital Colorado, Denver, Colorado, United States, 80204

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Ann Arbor

University of Michigan / CS Mott Children's Hospital, Ann Arbor, Michigan, United States, 48109

Omaha

University of Nebraska Medical Center / Children's Hospital and Medical Center, Omaha, Nebraska, United States, 68198

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Houston

Texas Children's Hospital Baylor College of Medicine, Houston, Texas, United States, 77030

Madison

American Family Children's Hospital / University of Wisconsin-Madison, Madison, Wisconsin, United States, 53792

Milwaukee

Children's Hospital of Wisconsin / Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent.
  • * Within 72 hours of the start of invasive mechanical ventilation and meet the criteria for pediatric ARDS (new infiltrate on chest imaging and a known ARDS risk factor within 7 days of the onset of hypoxemia) and either meet criteria for moderate or severe pediatric ARDS between 4-72 hours of IMV (OI ≥ 8 or OSI ≥ 7.5) OR have 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 with severe 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 for collection of longitudinal plasma samples.
  • * Non-conventional invasive mechanical ventilation (i.e. High Frequency Oscillatory Ventilation, Airway Pressure Release Ventilation) at the time of ICU admission
  • * ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICU admission
  • * Significant lower airways obstruction (examination of ventilator and capnography waveforms 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-conventional ventilation.

Ages Eligible for Study

0 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Los Angeles,

Anoopindar M Bhalla, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

2029-02-01