Phase
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
Either supine or prone positioning and either CMV or HFOV
Clinical Study ID
Ages 2-20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Intubated and mechanically ventilated with high moderate-severe PARDS for <48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥12 or OSI ≥10). We require two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume). A second blood gas is not required for OI ≥16.
Exclusion
Exclusion criteria:
Perinatal related lung disease
Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragmparalysis
Respiratory failure explained by cardiac failure or fluid overload
Cyanotic heart disease
Cardiomyopathy
Unilateral lung disease
Primary pulmonary hypertension
Intubated for status asthmaticus
Obstructive airway disease (e.g., Severe airways disease without parenchymalinvolvement or disease characterized by hypercapnia with FiO2 <0.30 and/or evidenceof increased resistance visible on the flow - time scalar and/or presence ofintrinsic PEEP)
Active air leak
Bronchiolitis obliterans
Post hematopoietic stem cell transplant; specifically, patients receiving continuoussupplemental oxygen for three or more days prior to intubation; receivingnoninvasive ventilation for more than 24 hours prior to intubation; receiving morethan one vasoactive medication at time of meeting inclusion criteria; spending morethan four days in the PICU prior to intubation; supported on or with immediate plansfor renal replacement therapies; with two or more allogeneic transplants; whorelapsed after the transplant; or with diffuse alveolar hemorrhage
Post lung transplant
Home ventilator dependent with baseline Oxygen Saturation Index (OSI) >6
Neuromuscular respiratory failure
Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) oranatomical obstruction of the lower airway (e.g., mediastinal mass)
Facial surgery or trauma in previous 2 weeks
Head trauma (managed with hyperventilation)
Intracranial bleeding
Unstable spine, femur or pelvic fractures
Open abdomen
Currently receiving more than 6 consecutive hours of either prone positioning orHFOV
Supported on ECMO during the current admission
Family/medical team not providing full support (patient treatment considered futile)
Previously enrolled in current study
Enrolled in any other interventional clinical trial not approved for co-enrollment
Known pregnancy
Study Design
Study Description
Connect with a study center
Queensland Children's Hospital
South Brisbane, Queensland
AustraliaSite Not Available
Royal Children's Hospital
Melbourne, Victoria
AustraliaSite Not Available
Perth Children's Hospital
Perth, Western Australia 6840
AustraliaSite Not Available
Children's Hospital at Westmead
Sydney,
AustraliaSite Not Available
Sabara Hospital Infantil
Sao Paulo,
BrazilSite Not Available
Hospital SEPACO
São Paulo,
BrazilSite Not Available
Alberta Children's Hospital
Calgary, Alberta T3B6A8
CanadaSite Not Available
Centre Hospitalier Universitaire Sainte Justine
Montréal, Quebec H3T1C5
CanadaSite Not Available
Guangzhou Women & Children's Hospital (Newtown)
Guangzhou,
ChinaSite Not Available
Guangzhou Women & Children's Hospital (Yuexiu)
Guangzhou,
ChinaSite Not Available
Münster University Hospital
Münster,
GermanySite Not Available
Rainbow Children's Hospital
Hyderabad,
IndiaSite Not Available
Hadassah Medical Center
Jerusalem,
IsraelSite Not Available
Policlinico S. Orsola-Malpighi University Hospital
Bologna,
ItalySite Not Available
Meyer Children's Hospital
Florence,
ItalySite Not Available
Instituto Giannina Gasilini
Genova,
ItalySite Not Available
Bambino Gesu Children's Hospital
Rome,
ItalySite Not Available
Bambino Gesu Children's Hospital (Area Rossa Unit)
Rome,
ItalySite Not Available
Chonnam National University Hospital
Gwangju,
Korea, Republic ofSite Not Available
University of Malaysia Medical Center
Kuala Lumpur,
MalaysiaSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
Starship Children's Hospital
Auckland,
New ZealandSite Not Available
Cruces University Hospital
Barakaldo,
SpainSite Not Available
Faculty of Medicine Ramathibodi Hospital
Bangkok,
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
ThailandSite Not Available
King Chulalongkorn Memorial Hospital
Bangkok, 10330
ThailandSite Not Available
Shaikh Khalifa Medical City
Abu Dhabi,
United Arab EmiratesSite Not Available
Birmingham Children's Hospital
Birmingham, UK
United KingdomSite Not Available
University Hospital Leicester NHS Trust
Leicester,
United KingdomSite Not Available
University Hospital Southampton NHS Foundation Trust
Southampton,
United KingdomSite Not Available
Children's of Alabama
Birmingham, Alabama 35233
United StatesSite Not Available
Banner Health
Phoenix, Arizona 85006
United StatesSite Not Available
Phoenix Children's Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Children's Hospital Orange County
Orange, California 92868
United StatesSite Not Available
Stanford Children's Health
Palo Alto, California 94304
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
UCSF Benioff Children's
San Francisco, California 94143
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesSite Not Available
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Nemours Foundation
Wilmington, Delaware 19803
United StatesSite Not Available
UF Shangs Children's Hospital
Gainesville, Florida 32610
United StatesSite Not Available
Holtz Children's Hospital
Miami, Florida 33136
United StatesSite Not Available
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96813
United StatesSite Not Available
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Riley Hospital for Children at IU Health
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Iowa Stead Family Chlldren's Hospital
Iowa City, Iowa 52242
United StatesSite Not Available
Norton Children's Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
Bloomberg Children's Center, Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
University of Maryland Medical Center-Children's Hospital
Baltimore, Maryland 21201
United StatesSite Not Available
CS Mott Children's Hospital
Ann Arbor, Michigan 48109
United StatesSite Not Available
Children's Hospital and Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of New Mexico Children's Hospital
Albuquerque, New Mexico 87106
United StatesSite Not Available
The Children's Hospital of Montefiore
Bronx, New York 10467
United StatesSite Not Available
Cohen Children's Medical Center
Queens, New York 11040
United StatesSite Not Available
UNC Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Duke Children's Hospital
Durham, North Carolina 27710
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
UH Rainbow Babies & Children
Cleveland, Ohio 44106
United StatesSite Not Available
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Penn State Children's Hospital
Hershey, Pennsylvania 17033
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19014
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
LeBonheur Children's Hospital
Memphis, Tennessee 38103
United StatesSite Not Available
Children's Health Dallas
Dallas, Texas 75235
United StatesSite Not Available
Medical City Dallas
Dallas, Texas 75230
United StatesSite Not Available
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
Children's Hospital of San Antonio
San Antonio, Texas 78207
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
Children's Hospital at Richmond at VCU
Richmond, Virginia 23219
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
American Family Children's Hospital, University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53201
United StatesSite Not Available
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