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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Driving Pressure Mechanical Ventilation | Active Comparator | A participant who is already on the breathing machine will have the driving pressure set to 25 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do. |
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| Low Driving Pressure Mechanical Ventilation | Active Comparator | A participant who is already on the breathing machine will have the driving pressure set to 15 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Driving Pressure Mechanical Ventilation | Other | 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 adhered to for the duration of the study. An Enlight 2100 Electrical Impedance Tomography (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Resolution of Hypoxemia | The primary outcome of PARMA is time (in hours) per participant to sustained resolution of hypoxemia, defined as being alive with 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 two consecutive measurements 4 hours apart. This outcome is censored at 28 days (672 hours). | Up to 672 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment | EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with recruited lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined. |
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Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Wiatrowski, B.A. | Contact | 7818123947 | wiatrowskh@chop.edu | |
| Stephen Famularo III, B.A. | Contact | 412-478-7643 | famularois@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nadir Yehya, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
De-identified trial dataset, stripped of all personal health information, will be shared with an existing NIH data repository (likely the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)).
Individual participant data (IPD) will be shared 1 year after main manuscript publication.
The IPD will be made readily available for research by qualified individuals within the scientific community as determined by DASH's regulatory and contractual requirements. The dataset will be accessible via the DASH platform.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2024 | Jul 8, 2025 |
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Eligible and consented subjects will be randomized within 24 hours of meeting study eligibility using 1:1 permuted blocks, using a randomization module available in Research Electronic Data CAPture (REDCap).
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| Low Driving Pressure Mechanical Ventilation | Other | 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 2100 (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs. |
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| 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 | EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with overdistended lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined. | 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 | EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The average value of center of ventilation for each study arm at the immediate post-randomization EIT will be compared. | 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 | Total number of participants all-cause mortality at 90 days after enrollment or hospital discharge. | From enrollment up to hospital discharge, no longer than 90 days. |
| Clinical End Point: all-cause mortality at 28 days | Total number of participants all-cause mortality at 28 days after enrollment or hospital discharge. | From enrollment up to hospital discharge, no longer than 28 days. |
| Clinical End Point: Pediatric ICU discharge | Total days per participant until Pediatric ICU discharge from start of enrollment. | From enrollment up to pediatric ICU discharge, no longer than 90 days |
| Clinical End Point: Hospital Discharge | Total days per participant until hospital discharge from enrollment. | From enrollment up to hospital discharge, no longer than 90 days. |
| Clinical End Point: Primary Cause of Death | Total number of participants who meet primary cause of death as defined as brain death, other neurologic, multiple organ dysfunction syndrome, refractory shock, refractory hemorrhage or refractory hypoxemia. | From enrollment up to hospital discharge, no longer than 90 days. |
| Clinical End Point: Ventilator Free Days | Total ventilator free days (VFDs) per participant at 28 days (defined as number of days alive and off invasive ventilation by day 28). | From enrollment up to hospital discharge, no longer than 28 days. |
| Clinical End Point: New Oxygenation- or Ventilator-dependency | Total number of participants with new oxygenation- or ventilator-dependency at time of discharge. | From enrollment up to hospital discharge, no longer than 90 days. |
| Safety Endpoint: pneumothorax requiring chest tube | Total number of participants with diagnosis of pneumothorax requiring chest tube. | From enrollment up to hospital discharge, no longer than 90 days. |
| Safety Endpoint: other air leak not requiring chest tube | Total number of participants with diagnosis of other air leak not requiring chest tubes. | From enrollment up to hospital discharge, no longer than 90 days. |
| Safety Endpoint: ventilator-associated pneumonia | Total number of participants with diagnosis of ventilator-associated pneumonia. | From enrollment up to hospital discharge, no longer than 90 days. |
| Safety Endpoint: new or progressive multiple organ dysfunction syndrome | Total number of participants with diagnosis of new or progressive multiple organ dysfunction syndrome. | From enrollment up to hospital discharge, no longer than 90 days. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2024 | Jul 8, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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