Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

Official title

Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial

Overview

Acute respiratory distress syndrome (ARDS) is a serious and potentially life-threatening lung condition that can affect children. Currently, ventilator settings commonly used in treatment are based on approaches developed for adults, and it remains unclear whether these settings are equally effective for children. Because children's bodies respond differently than adults', it is important to determine the most effective ventilator strategies specifically for pediatric patients. This study will compare two different ventilator approaches in children with ARDS to identify which method provides the greatest benefit. The findings will also help inform the design of a larger study in the future.

Interventions

• Other High Driving Pressure Mechanical Ventilation
  A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Dräger, Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 25 cmH2O (rate of pressure delivery). The Children's Hospital of Philadelphia (CHOP) PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adher
• Other Low Driving Pressure Mechanical Ventilation
  A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 15 cmH2O (rate of pressure delivery). CHOP PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 21

Primary outcome measures

• Sustained Resolution of Hypoxemia [Time frame: Up to 672 hours]

Secondary outcome measures (12)

• Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment [Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.]
• Imaging (Electrical Impedance Tomography (EIT)): Overdistension [Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.]
• Imaging (Electrical Impedance Tomography (EIT)): Center of Ventilation [Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.]
• Clinical End Point: all-cause mortality at 90 days [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]
• Clinical End Point: all-cause mortality at 28 days [Time frame: From enrollment up to hospital discharge, no longer than 28 days.]
• Clinical End Point: Pediatric ICU discharge [Time frame: From enrollment up to pediatric ICU discharge, no longer than 90 days]
• Clinical End Point: Hospital Discharge [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]
• Clinical End Point: Primary Cause of Death [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]
• Clinical End Point: Ventilator Free Days [Time frame: From enrollment up to hospital discharge, no longer than 28 days.]
• Clinical End Point: New Oxygenation- or Ventilator-dependency [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]
• Safety Endpoint: pneumothorax requiring chest tube [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]
• Safety Endpoint: other air leak not requiring chest tube [Time frame: From enrollment up to hospital discharge, no longer than 90 days.]

Eligibility criteria

Inclusion:

• age > 2 weeks (> 38 weeks corrected gestational age) and < 18 years (not yet had 18th birthday)
• acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
• ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset
• hypoxemia defined as PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) > 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) > 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O (rate of pressure delivery) on two consecutive measurements 4 hours apart and sustained at the time of consent and randomization
• bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI

Exclusion:

• hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
• non-palliated or unrepaired cyanotic congenital heart disease
• ventilated via tracheostomy at baseline prior to acute illness
• obstructive airway disease determined to be the primary cause of respiratory failure
• severe moribund state not expected to survive > 72 hours
• any limitations of care at time of screening
• escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening
• previous enrollment in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT07123961 · 24-022470

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗