Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369584
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-02
Brief Title:
Prone Position During ECMO in Pediatric Patients With Severe ARDS
Sponsor:
Seventh Medical Center of PLA General Hospital
Organization:
Seventh Medical Center of PLA General Hospital
Study Overview
Official Title:
Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome A Multi-center Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPAD
Brief Summary:
In 2023 the second Pediatric Acute Lung Injury Consensus Conference PALICC-2 updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome PARDS The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients However the effectiveness of Extracorporeal Membrane Oxygenation ECMO in treating severe PARDS has been fluctuating around 70 according to recent data from Extracorporeal Life Support Organization ELSO
In 2018 the Randomized Evaluation of Sedation Titration for Respiratory Failure RESTORE study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS However this retrospective study mainly focused on data from North America with significant variations in annual ECMO support cases among different centers which may introduce bias With advancements in ECMO technology and materials ECMO has become safer and easier to operate In recent years pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly
ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment When optimizing ventilator parameters titrating positive end expiratory pressure PEEP levels neuromuscular blockers prone positioning strict fluid management alone cannot maintain satisfactory oxygenation PF80mmHg or Oxygen Index OI 40 for over 4 hours or OI 20 for over 24 hours initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury
In 2018 the Randomized Evaluation of Sedation Titration for Respiratory Failure RESTORE study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS However this retrospective study mainly focused on data from North America with significant variations in annual ECMO support cases among different centers which may introduce bias With advancements in ECMO technology and materials ECMO has become safer and easier to operate In recent years pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly
ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment When optimizing ventilator parameters titrating positive end expiratory pressure PEEP levels neuromuscular blockers prone positioning strict fluid management alone cannot maintain satisfactory oxygenation PF80mmHg or Oxygen Index OI 40 for over 4 hours or OI 20 for over 24 hours initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None