Actively Recruiting
Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome
Led by Children's Hospital Los Angeles · Updated on 2024-11-15
1260
Participants Needed
10
Research Sites
226 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Los Angeles
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 37 weeks corrected gestational age to 21 years, including adults lacking capacity to consent
- Within 72 hours of starting invasive mechanical ventilation
- Meet criteria for pediatric ARDS with new infiltrate on chest imaging and known ARDS risk factor within 7 days of hypoxemia onset
- Meet criteria for moderate or severe pediatric ARDS between 4-72 hours of invasive mechanical ventilation (OI 2 or OSI 1 x 15 minutes between 0-4 hours of invasive mechanical ventilation
- Eligible subgroup for longitudinal blood collection includes children with severe pediatric ARDS (OI 2 or OSI 2 between 4-72 hours of invasive mechanical ventilation or OI 2 or OSI 4 for 15 minutes between 0-4 hours of invasive mechanical ventilation
You will not qualify if you...
- Use of non-conventional invasive mechanical ventilation (High Frequency Oscillatory Ventilation or Airway Pressure Release Ventilation) at ICU admission
- Receiving ECMO or inhaled nitric oxide or other inhaled pulmonary vasodilator therapy at ICU admission
- Significant lower airway obstruction based on ventilator and capnography waveform examination
- Air leak greater than 20% in endotracheal, tracheostomy, or thoracostomy tubes
- Use of 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
- No blood gas obtained prior to starting ECMO, inhaled nitric oxide, or non-conventional ventilation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Hospital Colorado
Denver, Colorado, United States, 80204
Not Yet Recruiting
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
4
University of Michigan / CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Active, Not Recruiting
5
University of Nebraska Medical Center / Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68198
Not Yet Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
7
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
8
Texas Children's Hospital Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
9
American Family Children's Hospital / University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
10
Children's Hospital of Wisconsin / Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
J
Jeni Kwok
CONTACT
A
Anoopindar Bhalla, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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