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
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 (P/F\<80mmHg 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.

• Informed consent obtained from the child's direct/legal guardian

Locations
Other Locations
China
Seventh medical center of Chinese PLA General Hospital
RECRUITING
Beijing
The Second School of Clinical Medicine, Southern Medical University
RECRUITING
Guangzhou
Gansu Provincial Maternal and Child Health Care Hospital
RECRUITING
Lanzhou
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Shenzhen Bao'an Maternity & Child Health Hospital
RECRUITING
Shenzhen
Xi'an Children's Hospital
RECRUITING
Xi'an
Henan Children's Hospital
RECRUITING
Zhengzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Xiaoyang Hong, M.D.
jyhongxy@163.com
13311057633
Backup
Zhe Zhao
derekpicu@outlook.com
18500179885
Time Frame
Start Date: 2024-05-09
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 7
Treatments
Experimental: prone position during ECMO in pediatric ARDS
Procedure: Prone positioning The process of prone positioning requires 5-6 people, with one person acting as the commander responsible for directing and monitoring the implementation of prone positioning. The process of monitoring includes ECMO flow and vital signs. The second person is in charge of the patient's head, including endotracheal intubation, ventilator lines, and jugular ECMO cannula. The third person is responsible for femoral ECMO cannula and central venous line. The fourth to sixth individuals are responsible for rotating the patient's torso towards the side without an ECMO tube. Before initiating prone ventilation, pressure ulcer protection patches should be placed to protect areas under pressure. During ECMO support period, each patient needs to undergo at least four sessions of prone ventilation. Each session should last between 16 to 24 hours.
No_intervention: supine position during ECMO in pediatric ARDS
Procedure: Supine position Patients assigned to supine will remain in a semi-recumbent position.
Sponsors
Collaborators: Zhengzhou Children's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Henan Provincial People's Hospital, Shenzhen Bao'an Maternal and Child Health Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Guangdong Provincial People's Hospital, Xian Children's Hospital
Leads: Seventh Medical Center of PLA General Hospital

This content was sourced from clinicaltrials.gov