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.
Study Type
OBSERVATIONAL
Enrollment
1,260
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGChildren's Hospital Colorado
Denver, Colorado, United States
NOT_YET_RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan / CS Mott Children's Hospital
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITINGUniversity of Nebraska Medical Center / Children's Hospital and Medical Center
Omaha, Nebraska, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGTexas Children's Hospital Baylor College of Medicine
Houston, Texas, United States
NOT_YET_RECRUITINGAmerican Family Children's Hospital / University of Wisconsin-Madison
Madison, Wisconsin, United States
NOT_YET_RECRUITINGChildren's Hospital of Wisconsin / Medical College of Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGNumber of participants that experience all-cause mortality within 28 days from start of invasive mechanical ventilation
28 day all-cause mortality
Time frame: From the start of invasive mechanical ventilation to 28 days
Number of participants that experience all-cause mortality within 90 days from start of invasive mechanical ventilation
90 day all-cause mortality
Time frame: From the start of invasive mechanical ventilation to 90 days
28-Day Ventilator-Free Days
The number of days within the first 28 days of invasive mechanical ventilation for ARDS that a patient is alive and free of mechanical ventilation.
Time frame: From the start of invasive mechanical ventilation to 28 days
The days on invasive mechanical ventilation for survivors of ARDS
The number of days that a patient that survives is on invasive mechanical ventilation (up to 90 days)
Time frame: From the start of invasive mechanical ventilation to the end of invasive mechanical ventilation (or 90 days after the start of invasive mechanical ventilation if the patient is still on invasive mechanical ventilation at 90 days)
The number of non-pulmonary organ failure free days within the first 14 days of invasive mechanical ventilation
Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify the number of days in the first 14 days of ARDS that a patient is alive and without any non-pulmonary organ failures.
Time frame: From the start of invasive mechanical ventilation to 14 days
The number of non-pulmonary organ failures 21 days after the start of invasive mechanical ventilation
Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. The number of non-pulmonary organ failures on day 21 after the start of invasive mechanical ventilation will be identified. Patients that experience mortality prior to 21 days will be considered to have failure of all non-pulmonary organs.
Time frame: 21 days after the start of invasive mechanical ventilation
The number of non-pulmonary organ failures 28 days after the start of invasive mechanical ventilation
Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. The number of non-pulmonary organ failures on day 28 after the start of invasive mechanical ventilation will be identified. Patients that experience mortality prior to 28 days will be considered to have failure of all non-pulmonary organs.
Time frame: 28 days after the start of invasive mechanical ventilation
The number of non-pulmonary organs that newly meet failure criteria or have an increase in the severity of organ failure within the first 14 days of invasive mechanical ventilation
Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify the number of organs during the first 14 days of invasive mechanical ventilation that either have worsening of the severity of failure or new failure after the first day of invasive mechanical ventilation.
Time frame: From the start of invasive mechanical ventilation to 14 days
The development of renal failure within the first 14 days of invasive mechanical ventilation
Renal organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify whether during the first 14 days of invasive mechanical ventilation there is new renal failure after the first day of invasive mechanical ventilation.
Time frame: From the start of invasive mechanical ventilation to 14 days
Non-pulmonary organ failure phenotypes that develop within the first 14 days of invasive mechanical ventilation
Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify 14-day non-pulmonary organ failure free phenotypes using clustering analyses.
Time frame: From the start of invasive mechanical ventilation to 14 days
Cumulative non-pulmonary organ failure severity in the first 14 days of invasive mechanical ventilation
Organ failure scores will be quantified daily with the Pediatric Logistic Organ Dysfunction (PELOD-2) score. Children that die will be assigned the maximum value. The score will be summed over the first 14 days of invasive mechanical ventilation.
Time frame: From the start of invasive mechanical ventilation to 14 days
The change in functional status score from baseline to hospital discharge
The baseline functional status score and the intensive care unit discharge functional status score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the functional status score at 90 days will be used rather than the functional status score at hospital discharge.
Time frame: From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation)
The change in pediatric overall performance score from baseline to hospital discharge
The baseline pediatric overall performance score and the hospital discharge pediatric overall performance score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the pediatric overall performance score at 90 days will be used rather than the pediatric overall performance score at hospital discharge.
Time frame: From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation)
The change in pediatric cerebral performance score from baseline to hospital discharge
The baseline pediatric cerebral performance score and the hospital discharge pediatric cerebral performance score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the pediatric cerebral performance score at 90 days will be used rather than the pediatric cerebral performance score at hospital discharge.
Time frame: From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation)
All-cause mortality or the use of extracorporeal membrane oxygenation (ECMO) therapy within 28 days after the start of invasive mechanical ventilation
Patients who experience mortality or use of ECMO within 28 days of the start of invasive mechanical ventilation
Time frame: From the start of invasive mechanical ventilation to 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.